FDA product code LZC: Medical Glove, Specialty
LZC is the FDA product code for medical glove, specialty. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel. FDA has cleared 79 510(k) submissions under LZC, 9 in the last five years, from 60 different applicants. The average 510(k) review took 157 days (median 133); 118 days on average over the last three years. FDA has posted 8 recalls for LZC devices, 2 initiated in the last five years.
Definition
A disposable medical glove (examination or surgeons) is a device that may or may not bear a trace amount of residual powder and is intended to be worn on the hand or finger(s) for medical purposes to prevent contamination. In addition, these gloves may have specialty claims such as chemotherapy, etc.
Classification
| Field | Value |
|---|---|
| Device name | Medical Glove, Specialty |
| 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 LZC
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 6 | 156 |
| 2018 | 6 | 132 |
| 2019 | 7 | 210 |
| 2020 | 3 | 165 |
| 2021 | 3 | 97 |
| 2022 | 7 | 81 |
| 2025 | 1 | 63 |
| 2026 | 1 | 173 |
Compare with all 510(k) review times · Search every LZC clearance
Top LZC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Wrp Asia Pacific Sdn. Bhd. | 5 | 2015-02-05 |
| Central Medicare Sdn Bhd | 4 | 2019-07-04 |
| Cardinalhealth | 3 | 2026-01-14 |
| Perusahaan Getah Asas Sdn. Bhd. | 3 | 2010-11-29 |
| Jr Engineering & Medical Technologies (M) Sdn. Bhd. | 2 | 2022-08-30 |
55 more applicants have LZC clearances. See the full list in Caduvo.
Most recent LZC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252313 | Cardinalhealth | Cardinal Health Nitrile Examination Gloves Extended Cuff | 2026-01-14 | 173 |
| K243959 | Lingshi Hongruida Health Protection Technology Co., Ltd. | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs | 2025-02-24 | 63 |
| K221157 | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | JR Medic | 2022-08-30 | 131 |
| K222449 | Better Care Plastic Technology Co., Ltd. | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) | 2022-08-27 | 12 |
| K220545 | Hl Rubber Industries Sdn Bhd | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs | 2022-05-26 | 90 |
Recalls for LZC devices
8 product recalls in 5 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2026-04-13.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2024 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code LZC?
LZC is the FDA product code for medical glove, specialty. It is a Class I device, regulated under 21 CFR 880.6250 and reviewed by the General Hospital panel.
What device class is LZC?
Class I, regulation 21 CFR 880.6250. Typical premarket route: 510(k).
How long does a 510(k) take for product code LZC?
Across 79 cleared submissions the average was 157 days from receipt to decision (median 133).
Which companies have the most LZC clearances?
Wrp Asia Pacific Sdn. Bhd. (5); Central Medicare Sdn Bhd (4); Cardinalhealth (3); Perusahaan Getah Asas Sdn. Bhd. (3); Jr Engineering & Medical Technologies (M) Sdn. Bhd. (2).
Have LZC devices been recalled?
Yes: 8 product recalls across 5 recall events; the most recent began 2026-04-13.
Next steps
- Run an FDA pathway report with predicate devices for product code LZC
- Run a recall and safety report across every LZC manufacturer
- Watch product code LZC 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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