The following data is part of a premarket notification filed by Tangshan Zhonghong Pulin Group Co., Ltd. with the FDA for Baldur Brand Vinyl Powder-free Examination Gloves.
| Device ID | K022091 |
| 510k Number | K022091 |
| Device Name: | BALDUR BRAND VINYL POWDER-FREE EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. 33235 TRANSIT AVE. Union City, CA 94587 |
| Contact | David Hu |
| Correspondent | David Hu TANGSHAN ZHONGHONG PULIN GROUP CO., LTD. 33235 TRANSIT AVE. Union City, CA 94587 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-27 |
| Decision Date | 2002-12-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970405800212 | K022091 | 000 |