FDA product code · General, Plastic Surgery
FYAGown, Surgical
Product code FYA covers Gown, Surgical, a Class II device regulated under 21 CFR 878.4040. FDA has cleared 296 devices in this code, 8 of them in the last 12 months. Median review time across the 296 most recent decisions is 128 days. openFDA lists 129 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 878.4040
- Review panel
- General, Plastic Surgery
- Clearances
- 296
What is happening in FYA right now?
FYA (Gown, Surgical) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-1563-2026, Z-1424-2026, Z-2129-2026, Z-2130-2026, Z-0897-2026). 6 first-time filers in the last 12 months, including New York Embroidery Studio and New York Embroidery Studio (NYES) (K261949, K252575, K260725, K253003, K251860). The code is crowded, scoring 94 of 100 — 169 companies hold a clearance here and 8 arrived in the last 12 months (FYA:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1563-2026, Z-1424-2026, Z-2129-2026, Z-2130-2026, Z-0897-2026 |
| New entrant | Worth knowing | K261949, K252575, K260725, K253003, K251860 |
| Crowding | Context | FYA:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in FYA?
FDA has cleared 296 devices under product code FYA since the 510(k) programme began in 1976, 8 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261949 | NYES Tuff Cuff L3 Disposable Gowns | New York Embroidery Studio | |
| K252575 | Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | New York Embroidery Studio (NYES) | |
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | Hindernis DE Mexico, S.A.P.I. DE C.V. | |
| K253243 | Cardinal Health Poly Reinforced Surgical Gown | Cardinal Health 200, LLC | |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) | Hubei Xinxin Non-Woven Co., Ltd. | |
| K251860 | Copioumed AAMI 3 Surgical Gown | Copioumed International, Inc. | |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | Yadu Medical (Henan) Co., Ltd. | |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Yadu Medical (Henan) Co., Ltd. | |
| K243522 | ViVi® Toga Premium | Thi Total Healthcare Innovation GmbH | |
| K242937 | Dream Medi Sterile Surgical Gown (SurgicalGownUL) | Dae Myung Chemical Co., Ltd. (Vietnam) |
How long does FDA review take for FYA?
The median FDA review time for FYA is 128 days, measured across the 296 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in FYA?
openFDA lists 129 recall records against product code FYA. A recall record covers one firm's corrective action and may span many device lots.
Z-1563-2026Open, ClassifiedMedline Industries, LP
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may result in brief delay in patient care. If delaminated product is used and surgical strikethrough occurs, there may be risk of infection.
Z-1424-2026Open, ClassifiedMedline Industries, LP
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-2129-2026Open, ClassifiedMedline Industries, LP
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-2130-2026Open, ClassifiedMedline Industries, LP
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Z-0897-2026Open, ClassifiedCardinal Health 200, LLC
Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years.
Showing the 5 most recently initiated of 129. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for FYA?
MAUDE holds 52 adverse-event reports naming product code FYA, 8 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in FYA unusual?
FYA does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 3 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 2 | Insufficient history | No expected range — too little history |
26 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered FYA in the last year?
6 companies filed in FYA for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| New York Embroidery Studio | K261949 | |
| New York Embroidery Studio (NYES) | K252575 | |
| Hindernis DE Mexico, S.A.P.I. DE C.V. | K260725 | |
| Hubei Xinxin Non-Woven Co., Ltd. | K253003 | |
| Copioumed International, Inc. | K251860 | |
| Yadu Medical (Henan) Co., Ltd. | K250564 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in FYA?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in FYA?
Across the 296 most recent decisions, these applicants filed most often in FYA.
| Applicant | Recent clearances |
|---|---|
| Standard Textile Co., Inc. | 14 |
| Medline Industries, Inc. | 13 |
| Kimberly-Clark Corp. | 11 |
| Allegiance Healthcare Corp. | 8 |
| The Sewing Source, Inc. | 8 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in FYA file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Medline Industries, LP | 16 | 2 |
| Kimberly-Clark Corporation | 12 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch FYA
Get an email the morning anything changes in FYA — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.