The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Nitrile Powder Fre Examination Gloves (blue) Tested For Use With Chemothreapy Drugs.
| Device ID | K091652 |
| 510k Number | K091652 |
| Device Name: | NITRILE POWDER FRE EXAMINATION GLOVES (BLUE) TESTED FOR USE WITH CHEMOTHREAPY DRUGS |
| Classification | Polymer Patient Examination Glove |
| Applicant | HARTALEGA SDN BHD NO. 7, KAWASAN PERUSAHAAN SURIA Bestari Jaya, MY 45600 |
| Contact | Nurul Aisyah Kong Bt Abdullah |
| Correspondent | Nurul Aisyah Kong Bt Abdullah 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 | 2009-06-09 |
| Decision Date | 2009-09-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00686864059608 | K091652 | 000 |
| 20686864016087 | K091652 | 000 |
| 20686864016094 | K091652 | 000 |
| 20686864016100 | K091652 | 000 |
| 00686864016113 | K091652 | 000 |
| 20686864047012 | K091652 | 000 |
| 20686864047029 | K091652 | 000 |
| 20686864047036 | K091652 | 000 |
| 20686864047043 | K091652 | 000 |
| 20686864047050 | K091652 | 000 |
| 00686864059523 | K091652 | 000 |
| 20686864016070 | K091652 | 000 |