The following data is part of a premarket notification filed by Tangshan Hongda Plastci Products Co Ltd with the FDA for Powder-free Vinyl Patient Examination Gloves.
| Device ID | K100326 |
| 510k Number | K100326 |
| Device Name: | POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TANGSHAN HONGDA PLASTCI PRODUCTS CO LTD NO. 209 BEI SI HUAN ZHONG ROAD HAIDIAN DISTRICT Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan TANGSHAN HONGDA PLASTCI PRODUCTS CO LTD NO. 209 BEI SI HUAN ZHONG ROAD HAIDIAN DISTRICT Beijing, CN 100083 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-04 |
| Decision Date | 2010-03-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10854344002537 | K100326 | 000 |
| 10854344002520 | K100326 | 000 |
| 10854344002513 | K100326 | 000 |
| 10854344002506 | K100326 | 000 |
| 10854344002490 | K100326 | 000 |
| 10818566012668 | K100326 | 000 |
| 10818566012651 | K100326 | 000 |
| 10818566012644 | K100326 | 000 |
| 10818566012637 | K100326 | 000 |