The following data is part of a premarket notification filed by Chatsworth Medical Supply, Inc. with the FDA for Powder Free Examination Gloves.
| Device ID | K931412 |
| 510k Number | K931412 |
| Device Name: | POWDER FREE EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | CHATSWORTH MEDICAL SUPPLY, INC. 21011 ITASCA STREET, #F Chatsworth, CA 91311 |
| Contact | Anthony Yeo |
| Correspondent | Anthony Yeo CHATSWORTH MEDICAL SUPPLY, INC. 21011 ITASCA STREET, #F Chatsworth, CA 91311 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-19 |
| Decision Date | 1993-11-30 |