The following data is part of a premarket notification filed by Marshall Latex Products Private Ltd. with the FDA for Patient Examination Gloves.
| Device ID | K893699 |
| 510k Number | K893699 |
| Device Name: | PATIENT EXAMINATION GLOVES |
| Classification | Latex Patient Examination Glove |
| Applicant | MARSHALL LATEX PRODUCTS PRIVATE LTD. B-13, MADRAS EXPORT PROCESSING ZONE KADAPPERI VILLAGE TAMBARA Madras 600 045, India, IN |
| Contact | Gopalan |
| Correspondent | Gopalan MARSHALL LATEX PRODUCTS PRIVATE LTD. B-13, MADRAS EXPORT PROCESSING ZONE KADAPPERI VILLAGE TAMBARA Madras 600 045, India, IN |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-15 |
| Decision Date | 1989-08-10 |