FDA product code LZA: Polymer Patient Examination Glove
LZA is the FDA product code for polymer patient examination glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel. FDA has cleared 1,180 510(k) submissions under LZA, 276 in the last five years, from 502 different applicants. The average 510(k) review took 118 days (median 94); 128 days on average over the last three years. FDA has posted 10 recalls for LZA devices, 3 initiated in the last five years.
Definition
A nitrile (or polymer) patient examination glove is a disposable device made of nitrile rubber or synthetic polymers 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.
Classification
| Field | Value |
|---|---|
| Device name | Polymer Patient Examination Glove |
| Device class | Class I |
| Regulation | 21 CFR 880.6250 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LZA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 44 | 145 |
| 2018 | 22 | 203 |
| 2019 | 25 | 208 |
| 2020 | 30 | 140 |
| 2021 | 139 | 136 |
| 2022 | 146 | 133 |
| 2023 | 62 | 131 |
| 2024 | 30 | 117 |
| 2025 | 24 | 128 |
| 2026 | 14 | 140 |
Compare with all 510(k) review times · Search every LZA clearance
Top LZA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hartalega Sdn Bhd | 33 | 2020-08-05 |
| Hartalega NGC Sdn. Bhd. | 24 | 2026-07-20 |
| Shen Wei (Usa), Inc. | 19 | 2016-11-17 |
| Siam Sempermed Corp., Ltd. | 17 | 2015-02-11 |
| Yty Industry (Manjung) Sdn Bhd | 16 | 2023-03-25 |
497 more applicants have LZA clearances. See the full list in Caduvo.
Most recent LZA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261793 | Maxter Healthcare, Inc. | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color) | 2026-09-09 | 103 |
| K262542 | Top Glove Sdn. Bhd. | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance Claim | 2026-09-09 | 48 |
| K260312 | Gmp Medicare Sdn. Bhd. | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric Acid | 2026-09-08 | 221 |
| K261749 | Cardinalhealth | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | 2026-09-02 | 97 |
| K260794 | Kossan International Sdn Bhd | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR | 2026-08-18 | 160 |
Recalls for LZA devices
10 product recalls in 5 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2026-08-14.
| Year | Recalls |
|---|---|
| 2019 | 4 |
| 2020 | 1 |
| 2026 | 3 |
Frequently asked questions
What is FDA product code LZA?
LZA is the FDA product code for polymer patient examination glove. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel.
What device class is LZA?
Class I, regulation 21 CFR 880.6250. Typical premarket route: 510(k).
How long does a 510(k) take for product code LZA?
Across 1,180 cleared submissions the average was 118 days from receipt to decision (median 94).
Which companies have the most LZA clearances?
Hartalega Sdn Bhd (33); Hartalega NGC Sdn. Bhd. (24); Shen Wei (Usa), Inc. (19); Siam Sempermed Corp., Ltd. (17); Yty Industry (Manjung) Sdn Bhd (16).
Have LZA devices been recalled?
Yes: 10 product recalls across 5 recall events; the most recent began 2026-08-14.
Next steps
- Run an FDA pathway report with predicate devices for product code LZA
- Run a recall and safety report across every LZA manufacturer
- Watch product code LZA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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