The following data is part of a premarket notification filed by Hartalega Sdn. Bhd. with the FDA for Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs (pink).
Device ID | K173137 |
510k Number | K173137 |
Device Name: | Nitrile Powder Free Examination Glove Tested For Use With Chemotherapy Drugs (Pink) |
Classification | Polymer Patient Examination Glove |
Applicant | Hartalega Sdn. Bhd. Dataran Sd Pju 9 Bandar Sri Damansara, MY 52200 |
Contact | Kuan Kam Hon |
Correspondent | Nurul Aisyah Kong Hartalega Sdn. Bhd No.7, Kawasan Perusahaan Suria Bestari Jaya, MY 45600 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-29 |
Decision Date | 2017-12-12 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00686864059479 | K173137 | 000 |
20686864046138 | K173137 | 000 |
20686864040822 | K173137 | 000 |
20686864040815 | K173137 | 000 |
20686864040808 | K173137 | 000 |