The following data is part of a premarket notification filed by Shijiazhuang Hongray Plastic Products Co., Ltd. with the FDA for Glove, Patient Examination, Vinyl (powdered).
| Device ID | K964321 |
| 510k Number | K964321 |
| Device Name: | GLOVE, PATIENT EXAMINATION, VINYL (POWDERED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. NO. 135 XIN-HUA WEST RD. Shijiazhuang, CN |
| Contact | Lin Chin Yu |
| Correspondent | Lin Chin Yu SHIJIAZHUANG HONGRAY PLASTIC PRODUCTS CO., LTD. NO. 135 XIN-HUA WEST RD. Shijiazhuang, CN |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-29 |
| Decision Date | 1997-01-09 |
| Summary: | summary |