The following data is part of a premarket notification filed by Safehealth Medical Supply Corp. with the FDA for Disposable Powder Free Vinyl Synthetic Gloves.
| Device ID | K955091 |
| 510k Number | K955091 |
| Device Name: | DISPOSABLE POWDER FREE VINYL SYNTHETIC GLOVES |
| Classification | Vinyl Patient Examination Glove |
| Applicant | SAFEHEALTH MEDICAL SUPPLY CORP. NO. 1,TOU KANG LI, HSUEH CHIA COUNTY Tainan Hsien, TW |
| Contact | P. M Yeh |
| Correspondent | P. M Yeh SAFEHEALTH MEDICAL SUPPLY CORP. NO. 1,TOU KANG LI, HSUEH CHIA COUNTY Tainan Hsien, TW |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-07 |
| Decision Date | 1995-12-15 |