FDA product code · General Hospital
LYYLatex Patient Examination Glove
Product code LYY covers Latex Patient Examination Glove, a Class I device regulated under 21 CFR 880.6250. FDA has cleared 1,954 devices in this code. Median review time across the 1,954 most recent decisions is 79 days. openFDA lists 6 recall records against this code.
Updated · ingest status · JSON
- Class
- Class I
- Regulation
- 21 CFR 880.6250
- Review panel
- General Hospital
- Clearances
- 1,954
What is happening in LYY right now?
LYY (Latex Patient Examination Glove): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
What does product code LYY cover?
LYY is FDA's product code for Latex Patient Examination Glove, a Class I device regulated under 21 CFR 880.6250.
A latex patient examination glove is a disposable device made of natural rubber latex that may or may not bear a trace amount of residual powder, and is intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.
Source: openFDA device/classification · record LYY · retrieved
How many devices has FDA cleared in LYY?
FDA has cleared 1,954 devices under product code LYY since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250069 | Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein | Comfort Rubber Gloves Industries Sdn. Bhd. | |
| K240266 | Latex Examination Glove Powder Free (Ocean Blue and Natural White) | Sri Trang Gloves (Thailand) Public Company Limited | |
| K230573 | Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) | Kossan International Sdn Bhd | |
| K223298 | Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) | Shandong Intco Medical Products Co, Ltd. | |
| K222612 | Powder-Free Latex examination gloves | Guangdong Kingfa Sci. & Tech.Co., Ltd. | |
| K221667 | Non Sterile Powder Free Latex Examination Glove | New Era Medicare Sdn. Bhd. | |
| K222348 | JR MEDIC | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | |
| K221374 | Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) | Hebei Titans Hongsen Medical Technology Co., Ltd. | |
| K222693 | Single-use medical latex examination gloves (LG100) | Fitone Latex Products Co., Ltd. Guangdong | |
| K221648 | Iconic Latex Glove | Iconic Medicare Sdn Bhd |
How long does FDA review take for LYY?
The median FDA review time for LYY is 79 days, measured across the 1,954 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 LYY?
openFDA lists 6 recall records against product code LYY. A recall record covers one firm's corrective action and may span many device lots.
Z-0051-2021TerminatedAnsell Healthcare Products LLC
Examination gloves were shipped inadvertently, without to verify barrier integrity.
Z-0712-2012TerminatedAdenna Inc
The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused.
Z-0909-06TerminatedGulf South Medical Supply Inc
FDA's laboratory analysis found holes in the gloves that exceeded the allowable limit. Gloves with holes compromise the integrity of the latex barrier and have the potential to allow hazardous substances to come into contact with the user's skin.
Z-1045-03TerminatedHenry Schein, Inc.
FDA's analysis revealed defects (holes) in the latex gloves.
Z-1046-03TerminatedHenry Schein, Inc.
FDA's analysis revealed defects (holes) in the latex gloves.
Showing the 5 most recently initiated of 6. 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 LYY?
MAUDE holds 8 adverse-event reports naming product code LYY, 1 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 LYY unusual?
LYY 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 | |
| 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 |
5 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.
What are the predicate devices in LYY?
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 LYY?
Across the 1,954 most recent decisions, these applicants filed most often in LYY.
| Applicant | Recent clearances |
|---|---|
| Wembley Rubber Products (M) Sdn Bhd | 37 |
| Sgmp Co., Ltd. | 25 |
| Hartalega Sdn Bhd | 19 |
| Siam Sempermed Corp., Ltd. | 19 |
| Perusahaan Getah Asas Sdn. Bhd. | 16 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
Source: openFDA device/510k · retrieved
Watch LYY
Get an email the morning anything changes in LYY — 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.