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FDA product code · General Hospital · Class 1

LZA: Polymer Patient Examination Glove

LZA is FDA's product code for "Polymer Patient Examination Glove": a Class 1 device classified under 21 CFR 880.6250, reviewed by the General Hospital panel.

510(k) review time for LZA

Across 492 510(k) clearances under LZA decided from 2018-01-01 to 2026-10-06, the median was 112 days from FDA receipt to decision. Half took between 84 and 197 days, and 80% were decided within 217 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, LZA, decisions 2018-01-01 to 2026-10-06 (n = 492)
Fastest5
25th percentile84
Median112
75th percentile197
80th percentile217
90th percentile260
Slowest808
Median days by decision year, LZA (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
201817822
201921225
202010130
2021111139
2022111146
20239262
20248930
202511024
2026 (to 10-06, partial)11114

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.

LZA in the public FDA record

Records naming LZA, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years1,176
Establishment listings1,955
GUDID device identifiers9,972

Counts of records, not of devices or events. Adverse event reports for LZA 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 LZA

13 FDA recognized consensus standards cite LZA, 7 of them recognized only in part, among them ANSI ASQ Z1.4-2003 (R2018); ASTM D6978-05(2023); ASTM D6124-06(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
  • 6-178 ASTM D6124-06(2022) (partial recognition) — Standard Test Method for Residual Powder on Medical Gloves
  • 6-354 ASTM D7907-14 (Reapproved 2019) — Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
  • 6-401 ASTM D7160-16 (Reapproved 2023) — Standard Practice for Determination of Expiration Dating for Medical Gloves
  • 6-424 ASTM D5151-19(2023) — Standard Test Method for Detection of Holes in Medical Gloves
  • 6-440 ASTM D3578-19(2023) (partial recognition) — Standard Specification for Rubber Examination Gloves
  • 6-442 ASTM D6977-19(2023) (partial recognition) — Standard Specification for Polychloroprene Examination Gloves for Medical Application
  • 6-444 ASTM D7103-19(2023) — Standard Guide for Assessment of Medical Gloves
  • 6-445 ASTM D5250-19(2023) (partial recognition) — Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
  • 6-446 ASTM D6319-19(2023) (partial recognition) — Standard Specification for Nitrile Examination Gloves for Medical Application
  • 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

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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