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 |