The following data is part of a premarket notification filed by Asia Pacific Latex Sdn Bhd with the FDA for Nitrile Patient Examination Glove Powder Free.
| Device ID | K982274 |
| 510k Number | K982274 |
| Device Name: | NITRILE PATIENT EXAMINATION GLOVE POWDER FREE |
| Classification | Polymer Patient Examination Glove |
| Applicant | ASIA PACIFIC LATEX SDN BHD 14, JALAN TAIPING Kuala Kangsar, Perak, MY 33000 |
| Contact | Lee Soon Hong |
| Correspondent | Lee Soon Hong ASIA PACIFIC LATEX SDN BHD 14, JALAN TAIPING Kuala Kangsar, Perak, MY 33000 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-29 |
| Decision Date | 1998-08-11 |