The following data is part of a premarket notification filed by Allerderm Laboratories, Inc. with the FDA for More Chain Powder Free Vinyl Examination Gloves.
| Device ID | K951007 |
| 510k Number | K951007 |
| Device Name: | MORE CHAIN POWDER FREE VINYL EXAMINATION GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ALLERDERM LABORATORIES, INC. P.O. BOX 931 Mill Valley, CA 94941 |
| Contact | Benjamin K Lee |
| Correspondent | Benjamin K Lee ALLERDERM LABORATORIES, INC. P.O. BOX 931 Mill Valley, CA 94941 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-28 |
| Decision Date | 1995-07-26 |