LZA — Polymer Patient Examination Glove Class I
FDA product code LZA covers "Polymer Patient Examination Glove", a Class I medical device regulated under 21 CFR 880.6250. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LZA
- Device Class
- Class I
- Regulation Number
- 880.6250
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262542 | top glove sdn. bhd | Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitril | September 9, 2026 |
| K261793 | maxter healthcare | Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs an | September 9, 2026 |
| K260312 | gmp medicare sdn. bhd | Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy | September 8, 2026 |
| K261749 | cardinalhealth | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy | September 2, 2026 |
| K260794 | kossan international | NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT E | August 18, 2026 |
| K262014 | o and m halyard | PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile | July 21, 2026 |
| K254285 | hartalega ngc sdn. bhd | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs | July 20, 2026 |
| K252117 | sw technologies | Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use | June 24, 2026 |
| K253824 | kanglongda vietnam protection technology company limited | Powder Free Nitrile Examination Gloves Non-Sterile Black | June 18, 2026 |
| K260867 | hartalega ngc sdn. bhd | Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs an | June 17, 2026 |
| K260806 | vista industries | Nitrile Disposable Examination Gloves | June 3, 2026 |
| K260703 | s and s glove corporation | Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Dr | June 3, 2026 |
| K253160 | basic medical technology | Syntex Exam Gloves | January 23, 2026 |
| K252549 | kossan international | Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tes | January 13, 2026 |
| K251141 | mercator medical (thailand) | Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested | November 17, 2025 |
| K250861 | hartalega ngc sdn. bhd | Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fe | October 23, 2025 |
| K252075 | program insite | Program insite® Powder-Free, Disposable Nitrile Exam Gloves | October 17, 2025 |
| K251716 | basic medical technology | Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid F | August 27, 2025 |
| K252244 | ever global (vietnam) enterprise corporation | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use Wit | August 21, 2025 |
| K243604 | o and m halyard | Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, | August 18, 2025 |