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 |