FDA product code · General Hospital · Class 1
LZC: Medical Glove, Specialty
LZC is FDA's product code for "Medical Glove, Specialty": a Class 1 device classified under 21 CFR 880.6250, reviewed by the General Hospital panel.
510(k) review time for LZC
Across 28 510(k) clearances under LZC decided from 2018-01-01 to 2026-10-06, the median was 109 days from FDA receipt to decision. Half took between 85 and 188 days, and 80% were decided within 205 days. These are past clearances, not a forecast for a new submission.
| Fastest | 12 |
|---|---|
| 25th percentile | 85 |
| Median | 109 |
| 75th percentile | 188 |
| 80th percentile | 205 |
| 90th percentile | 227 |
| Slowest | 363 |
| Year | Median days | n |
|---|---|---|
| 2018 | 105 | 6 |
| 2019 | 200 | 7 |
| 2022 | 85 | 7 |
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.
LZC in the public FDA record
| 510(k) clearances, all years | 79 |
|---|---|
| Device recalls | 8 |
| Establishment listings | 1,093 |
| GUDID device identifiers | 3,794 |
Counts of records, not of devices or events. Adverse event reports for LZC 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 LZC
5 FDA recognized consensus standards cite LZC, 1 of them recognized only in part, among them ASTM D6355-07(2022); ASTM D7907-14 (Reapproved 2019); ASTM D6499-18. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 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
- 6-496 ASTM F739-20 (partial recognition) — Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
- 6-515 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.