The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Prevention Breathable, Impervious Surgical Gowns.
| Device ID | K043017 |
| 510k Number | K043017 |
| Device Name: | PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS |
| Classification | Gown, Surgical |
| Applicant | MEDLINE INDUSTRIES, INC. 1170 S. NORTHPOINT BLVD. Waukegan, IL 60085 |
| Contact | Lara N Simmons |
| Correspondent | Lara N Simmons MEDLINE INDUSTRIES, INC. 1170 S. NORTHPOINT BLVD. Waukegan, IL 60085 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-02 |
| Decision Date | 2005-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888277988453 | K043017 | 000 |
| 10889942507627 | K043017 | 000 |
| 10888277988460 | K043017 | 000 |