The following data is part of a premarket notification filed by Hartalega Sdn Bhd with the FDA for Blue Chlorinated Powder Free Latex Examination Gloves With Protein Content Labeling Claim Of 50 Micrograms Or Less..
| Device ID | K993722 |
| 510k Number | K993722 |
| Device Name: | BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS. |
| Classification | Latex Patient Examination Glove |
| Applicant | HARTALEGA SDN BHD 9 JLN KANAN,KEPONG GARDEN INDUSTR ESTATE Kuala Lumpur, 52100, MY |
| Contact | Kuan Kam Hon |
| Correspondent | Kuan Kam Hon HARTALEGA SDN BHD 9 JLN KANAN,KEPONG GARDEN INDUSTR ESTATE Kuala Lumpur, 52100, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-03 |
| Decision Date | 1999-11-23 |