The following data is part of a premarket notification filed by Zibo Hengchang Plastic & Rubber Products Co., Ltd. with the FDA for Vinyl Exam Glove, Powder-free, Non-sterile.
| Device ID | K042952 |
| 510k Number | K042952 |
| Device Name: | VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO HENGCHANG PLASTIC & RUBBER PRODUCTS CO., LTD. 10 SETON COURT Rancho Mirage, CA 92270 |
| Contact | Mary Anne Doucette |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-10-26 |
| Decision Date | 2005-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00612479188105 | K042952 | 000 |
| 00612479188082 | K042952 | 000 |
| 00612479188068 | K042952 | 000 |
| 00612479188044 | K042952 | 000 |
| 06949809200010 | K042952 | 000 |