The following data is part of a premarket notification filed by Ppp Medical And Safety Products Company Limited with the FDA for Powdered Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K110970 |
| 510k Number | K110970 |
| Device Name: | POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED ROOM 1606 BUILDING 1 JIAN XIAN YUAN NO.209 BEI SI HUAN ZHONG Rd. Hai Di, Beijing, CN 100083 |
| Contact | Chu Xiaoan |
| Correspondent | Chu Xiaoan PPP MEDICAL AND SAFETY PRODUCTS COMPANY LIMITED ROOM 1606 BUILDING 1 JIAN XIAN YUAN NO.209 BEI SI HUAN ZHONG Rd. Hai Di, Beijing, CN 100083 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-06 |
| Decision Date | 2011-07-21 |
| Summary: | summary |