LZC · Medical Glove, Specialty
General Hospital · 21 CFR 880.6250 · Class 1
Overview
| Product Code | LZC |
|---|---|
| Device Name | Medical Glove, Specialty |
| Regulation | 21 CFR 880.6250 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| 3rd-Party Reviewable | Yes |
Identification
A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.
Classification Rationale
Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
Recent Cleared Devices (20 of 79)
Showing 20 most recent of 79 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff | Cardinalhealth | Jan 14, 2026 | SESE |
| K243959 | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs | Lingshi Hongruida Health Protection Technology Co., Ltd. | Feb 24, 2025 | SESE |
| K221157 | JR Medic | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | Aug 30, 2022 | SESE |
| K222449 | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) | Better Care Plastic Technology Co., Ltd. | Aug 27, 2022 | SESE |
| K220545 | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs | Hl Rubber Industries Sdn Bhd | May 26, 2022 | SESE |
| K220491 | Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs | Hainan Asther Medical Equipment Co., Ltd. | May 14, 2022 | SESE |
| K220353 | Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs | Niujian Technology Co., Ltd. | Mar 31, 2022 | SESE |
| K213910 | Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs | Changzhou Universal Medical Equipment Co., Ltd. | Mar 10, 2022 | SESE |
| K213325 | Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs | Anhui Xinyisheng Medical Technology Co.,Ltd | Jan 28, 2022 | SESE |
| K213076 | AspenMed+ | Aspen Glove Sdn. Bhd. | Dec 20, 2021 | SESE |
| K212639 | Disposable Medical Nitrile Examination Gloves (Non sterile) | Jiangsu Nanfang Medical Co., Ltd. | Dec 8, 2021 | SESE |
| K212827 | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs | Jr Engineering & Medical Technologies (M) Sdn. Bhd. | Dec 6, 2021 | SESE |
| K200633 | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove | 0 & M Halyard, Inc. | Oct 11, 2020 | SESE |
| K201390 | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) | Medline Industires, Inc. | Sep 18, 2020 | SESE |
| K193555 | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate | Ever Global (Vietnam) Enterprise Corp | Jun 4, 2020 | SESE |
| K191230 | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves | O&M Halyard, Inc. | Nov 8, 2019 | SESE |
| K183562 | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs | Encompass Industries Sdn. Bhd. | Oct 23, 2019 | SESE |
| K182382 | Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink | Gmp Medicare Sdn Bhd (F25) | Aug 29, 2019 | SESE |
| K183149 | Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim | Central Medicare Sdn Bhd | Jul 4, 2019 | SESE |
| K190159 | Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove | Showa Best Glove, Inc. | May 6, 2019 | SESE |
Top Applicants
- Wrp Asia Pacific Sdn. Bhd. — 5 clearances
- Central Medicare Sdn Bhd — 4 clearances
- Cardinalhealth — 3 clearances
- Perusahaan Getah Asas Sdn. Bhd. — 3 clearances
- Acufex Microsurgical, Inc. — 2 clearances
