The following data is part of a premarket notification filed by Shijiazhuang Wally Plastics Co., Ltd with the FDA for Powder Free Synthetic Vinyl Examination Gloves.
| Device ID | K022600 |
| 510k Number | K022600 |
| Device Name: | POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SHIJIAZHUANG WALLY PLASTICS CO., LTD 1202 S. RTE 31 Mc Henry, IL 60050 |
| Contact | Antonio L Giaccio |
| Correspondent | Antonio L Giaccio SHIJIAZHUANG WALLY PLASTICS CO., LTD 1202 S. RTE 31 Mc Henry, IL 60050 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-05 |
| Decision Date | 2002-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B754700201 | K022600 | 000 |
| B754700151 | K022600 | 000 |
| B754700101 | K022600 | 000 |
| B754700051 | K022600 | 000 |