The following data is part of a premarket notification filed by Kimberly-clark Corp. with the FDA for Spunguard Scrub Suit.
| Device ID | K831207 |
| 510k Number | K831207 |
| Device Name: | SPUNGUARD SCRUB SUIT |
| Classification | Suit, Surgical |
| Applicant | KIMBERLY-CLARK CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FXO |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-12 |
| Decision Date | 1983-05-16 |