The following data is part of a premarket notification filed by Jf Trading Co., Ltd. with the FDA for Examination Gloves, Powder Free.
| Device ID | K935384 |
| 510k Number | K935384 |
| Device Name: | EXAMINATION GLOVES, POWDER FREE |
| Classification | Latex Patient Examination Glove |
| Applicant | JF TRADING CO., LTD. 304-B, E. LAWRENCE BLVD. P.O. BOX 1082 Avondale, AZ 85323 |
| Contact | Neeraj Kumar |
| Correspondent | Neeraj Kumar JF TRADING CO., LTD. 304-B, E. LAWRENCE BLVD. P.O. BOX 1082 Avondale, AZ 85323 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-08 |
| Decision Date | 1994-09-19 |