The following data is part of a premarket notification filed by Ganz Industries Sdn. Bhd. with the FDA for Pre Powdered Latex Examination Gloves.
| Device ID | K954487 |
| 510k Number | K954487 |
| Device Name: | PRE POWDERED LATEX EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | GANZ INDUSTRIES SDN. BHD. PT. NO. 3367, JALAN AM 2, ARAB MALAYSIAN IND. PK. Nilai, Negeri Sembilan, MY 71800 |
| Contact | Gan Seong Khiam |
| Correspondent | Gan Seong Khiam GANZ INDUSTRIES SDN. BHD. PT. NO. 3367, JALAN AM 2, ARAB MALAYSIAN IND. PK. Nilai, Negeri Sembilan, MY 71800 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-27 |
| Decision Date | 1996-03-15 |