LZC — Medical Glove, Specialty Class I
Classification Details
- Product Code
- LZC
- Device Class
- Class I
- Regulation Number
- 880.6250
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252313 | cardinalhealth | Cardinal Health Nitrile Examination Gloves Extended Cuff | January 14, 2026 |
| K243959 | lingshi hongruida health protection technology co | Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use wi | February 24, 2025 |
| K221157 | jr engineering and medical technologies (m) sdn. bhd | JR Medic | August 30, 2022 |
| K222449 | better care plastic technology co | Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs A | August 27, 2022 |
| K220545 | hl rubber industries | Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy D | May 26, 2022 |
| K220491 | hainan asther medical equipment co | Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy | May 14, 2022 |
| K220353 | niujian technology co | Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Dru | March 31, 2022 |
| K213910 | changzhou universal medical equipment co | Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy | March 10, 2022 |
| K213325 | anhui xinyisheng medical technology co | Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy | January 28, 2022 |
| K213076 | aspen glove sdn. bhd | AspenMed+ | December 20, 2021 |
| K212639 | jiangsu nanfang medical co | Disposable Medical Nitrile Examination Gloves (Non sterile) | December 8, 2021 |
| K212827 | jr engineering and medical technologies (m) sdn. bhd | Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemoth | December 6, 2021 |
| K200633 | 0 and m halyard | Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Ni | October 11, 2020 |
| K201390 | medline industires | Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemothe | September 18, 2020 |
| K193555 | ever global (vietnam) enterprise | Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use Wit | June 4, 2020 |
| K191230 | o and m halyard | Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile | November 8, 2019 |
| K183562 | encompass industries sdn. bhd | Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Co | October 23, 2019 |
| K182382 | gmp medicare sdn bhd (f25) | Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powd | August 29, 2019 |
| K183149 | central medicare | Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low | July 4, 2019 |
| K190159 | showa best glove | Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove | May 6, 2019 |