FDA product code · General Hospital · Class 1
LYY: Latex Patient Examination Glove
LYY is FDA's product code for "Latex Patient Examination Glove": a Class 1 device classified under 21 CFR 880.6250, reviewed by the General Hospital panel.
510(k) review time for LYY
Across 30 510(k) clearances under LYY decided from 2018-01-01 to 2026-10-06, the median was 143 days from FDA receipt to decision. Half took between 99 and 257 days, and 80% were decided within 266 days. These are past clearances, not a forecast for a new submission.
| Fastest | 18 |
|---|---|
| 25th percentile | 99 |
| Median | 143 |
| 75th percentile | 257 |
| 80th percentile | 266 |
| 90th percentile | 344 |
| Slowest | 455 |
| Year | Median days | n |
|---|---|---|
| 2021 | 188 | 8 |
| 2022 | 150 | 14 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
LYY in the public FDA record
| 510(k) clearances, all years | 1,954 |
|---|---|
| Establishment listings | 614 |
| GUDID device identifiers | 1,675 |
Counts of records, not of devices or events. Adverse event reports for LYY are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite LYY
10 FDA recognized consensus standards cite LYY, 3 of them recognized only in part, among them ANSI ASQ Z1.4-2003 (R2018); ASTM D6978-05(2023); ASTM D6355-07(2022). Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 5-62 ANSI ASQ Z1.4-2003 (R2018) — Sampling Procedures and Tables for Inspection by Attributes
- 6-147 ASTM D6978-05(2023) — Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
- 6-214 ASTM D6355-07(2022) — Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
- 6-354 ASTM D7907-14 (Reapproved 2019) — Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
- 6-411 ASTM D6499-18 — Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
- 6-440 ASTM D3578-19(2023) (partial recognition) — Standard Specification for Rubber Examination Gloves
- 6-444 ASTM D7103-19(2023) — Standard Guide for Assessment of Medical Gloves
- 6-496 ASTM F739-20 (partial recognition) — Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
- 6-497 ASTM D7866-23 (partial recognition) — Standard Specification for Radiation Attenuating Protective Gloves
- 6-515 ASTM D6499-24 — Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.