The following data is part of a premarket notification filed by Crdlight Optoelectronic Technology Co., Ltd with the FDA for Disposable Powder Free Nitrile Exam Gloves (tested For Use With Chemotherapy Drugs).
| Device ID | K212532 |
| 510k Number | K212532 |
| Device Name: | Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) |
| Classification | Polymer Patient Examination Glove |
| Applicant | CRDLight Optoelectronic Technology Co., Ltd Floor 1-5 Building No.7 & Floor 1-4 Building No.5 No.18 Xinyi Road, Jianghai Jiangmen, CN |
| Contact | Fishy Liang |
| Correspondent | Ivy Wang Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-11 |
| Decision Date | 2021-11-11 |