The following data is part of a premarket notification filed by Cranberry (m) Sdn. Bhd. with the FDA for Powder Free Latex Examination Gloves.
| Device ID | K935946 |
| 510k Number | K935946 |
| Device Name: | POWDER FREE LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | CRANBERRY (M) SDN. BHD. TASEK INDUSTRIAL ESTATE 31400 IPOH, Perak, Malaysia, MY |
| Contact | Chuah Chaw Teo |
| Correspondent | Chuah Chaw Teo CRANBERRY (M) SDN. BHD. TASEK INDUSTRIAL ESTATE 31400 IPOH, Perak, Malaysia, MY |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-06-21 |