The following data is part of a premarket notification filed by Zhonghong Pulin Medical Products Co., Ltd. with the FDA for Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested For Use With Chemotherapy Drugs.
| Device ID | K171873 |
| 510k Number | K171873 |
| Device Name: | Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested For Use With Chemotherapy Drugs |
| Classification | Polymer Patient Examination Glove |
| Applicant | Zhonghong Pulin Medical Products Co., Ltd. Pachigang Industrial Park, Luannan County Tangshan, CN 063502 |
| Contact | Jinge Li |
| Correspondent | Da Shi Zhonghong Pulin Medical Products Co.,Ltd. 800 - 10 Four Seasons Place Toronto, CA M9b 6h7 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-23 |
| Decision Date | 2017-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00686864059509 | K171873 | 000 |
| 20850036987110 | K171873 | 000 |
| 20850036987103 | K171873 | 000 |
| 20850036987097 | K171873 | 000 |
| 20850036987080 | K171873 | 000 |
| 20686864060158 | K171873 | 000 |
| 20686864060141 | K171873 | 000 |
| 20686864060134 | K171873 | 000 |
| 20686864060127 | K171873 | 000 |
| 20850036987127 | K171873 | 000 |
| 20850036987189 | K171873 | 000 |
| 20850036987196 | K171873 | 000 |
| 20686864059411 | K171873 | 000 |
| 20686864059404 | K171873 | 000 |
| 20686864059398 | K171873 | 000 |
| 20686864059381 | K171873 | 000 |
| 20686864059374 | K171873 | 000 |
| 20850036987226 | K171873 | 000 |
| 20850036987219 | K171873 | 000 |
| 20850036987202 | K171873 | 000 |
| 20686864060110 | K171873 | 000 |