The following data is part of a premarket notification filed by Sri Johani Sdn. Bhd. with the FDA for Sterile Latex Examination Glove.
| Device ID | K900868 |
| 510k Number | K900868 |
| Device Name: | STERILE LATEX EXAMINATION GLOVE |
| Classification | Latex Patient Examination Glove |
| Applicant | SRI JOHANI SDN. BHD. 40 DOGWOOD DR. Chester, NJ 07930 |
| Contact | Robert S Kennedy |
| Correspondent | Robert S Kennedy SRI JOHANI SDN. BHD. 40 DOGWOOD DR. Chester, NJ 07930 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-23 |
| Decision Date | 1990-03-09 |