The following data is part of a premarket notification filed by Tangshan Zhonghong Pulin Group Co., Ltd. with the FDA for Baldur Brand Vinyl Powdered Examination Gloves, Sun Flower Gloves Co., Ltd.
| Device ID | K022336 |
| 510k Number | K022336 |
| Device Name: | BALDUR BRAND VINYL POWDERED EXAMINATION GLOVES, SUN FLOWER GLOVES CO., LTD |
| 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 | 2002-07-18 |
| Decision Date | 2002-10-11 |
| Summary: | summary |