The following data is part of a premarket notification filed by Hartalega Sdb. Bhd. with the FDA for Latex Powdered Examination Gloves With Protein Labeling Claim Of 200 Microgram Or Less Per Gram Of Glove.
| Device ID | K142270 |
| 510k Number | K142270 |
| Device Name: | LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | HARTALEGA SDB. BHD. DATARAN SD PJU9 Bandar Sri Damansara, MY 52200 |
| Contact | Kuan Kam Hon |
| Correspondent | Nurul Aisyah Kong Bt Abdullah HARTALEGA SDB. BHD. NO.7 KAWASAN PERUSAHAAN SURIA Bestari Jaya, MY 45600 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-15 |
| Decision Date | 2014-11-25 |