The following data is part of a premarket notification filed by Hartalega Ngc Sdn. Bhd. with the FDA for Latex Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove.
| Device ID | K183536 |
| 510k Number | K183536 |
| Device Name: | Latex Powder Free Surgical Glove With Protein Labeling Claim Of 50 Microgram Or Less Per Gram Of Glove |
| Classification | Surgeon's Gloves |
| Applicant | Hartalega Ngc Sdn. Bhd. Kawasan Perindustrian Tanjung Sepang, MY 43900 |
| Contact | Kuan Mun Leong |
| Correspondent | Nurul Aisyah Kong Hartalega Ngc Sdn. Bhd. Dataran Sd Pju 9 Bandar Sri Damansara, MY 52200 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-19 |
| Decision Date | 2019-08-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00612479261426 | K183536 | 000 |
| 00612479261396 | K183536 | 000 |
| 00612479261365 | K183536 | 000 |
| 00612479261334 | K183536 | 000 |
| 00612479261303 | K183536 | 000 |
| 00612479261273 | K183536 | 000 |
| 00612479261242 | K183536 | 000 |