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 |