The following data is part of a premarket notification filed by Perusahaan Getah Asas Sdn Bhd with the FDA for Patient Examination Gloves (latex)(powdered).
| Device ID | K891640 |
| 510k Number | K891640 |
| Device Name: | PATIENT EXAMINATION GLOVES (LATEX)(POWDERED) |
| Classification | Latex Patient Examination Glove |
| Applicant | PERUSAHAAN GETAH ASAS SDN BHD LOT 1641, JALAN RAJA LUMU, KAW PERINDUSTRIAN, PKNS PANDAMARAN 42000 Port Kelang, S.d.e., MY |
| Contact | Choon Kwang |
| Correspondent | Choon Kwang PERUSAHAAN GETAH ASAS SDN BHD LOT 1641, JALAN RAJA LUMU, KAW PERINDUSTRIAN, PKNS PANDAMARAN 42000 Port Kelang, S.d.e., MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-03-17 |
| Decision Date | 1989-05-22 |