The following data is part of a premarket notification filed by Kimberly-clark Corporation with the FDA for Aero Blue Performance Surgical Gown.
| Device ID | K140539 |
| 510k Number | K140539 |
| Device Name: | AERO BLUE PERFORMANCE SURGICAL GOWN |
| Classification | Gown, Surgical |
| Applicant | KIMBERLY-CLARK CORPORATION 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
| Contact | David M Lee |
| Correspondent | David M Lee KIMBERLY-CLARK CORPORATION 1400 HOLCOMB BRIDGE ROAD Roswell, GA 30076 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-04 |
| Decision Date | 2014-06-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30680651419348 | K140539 | 000 |
| 30680651418709 | K140539 | 000 |
| 30680651418716 | K140539 | 000 |
| 30680651418723 | K140539 | 000 |
| 30680651418730 | K140539 | 000 |
| 30680651418747 | K140539 | 000 |
| 30680651419287 | K140539 | 000 |
| 30680651419294 | K140539 | 000 |
| 30680651419300 | K140539 | 000 |
| 30680651417382 | K140539 | 000 |
| 30680651417375 | K140539 | 000 |
| 30680651417238 | K140539 | 000 |
| 30680651417245 | K140539 | 000 |
| 30680651417269 | K140539 | 000 |
| 30680651417320 | K140539 | 000 |
| 30680651417337 | K140539 | 000 |
| 30680651417344 | K140539 | 000 |
| 30680651417351 | K140539 | 000 |
| 30680651417368 | K140539 | 000 |
| 30680651419317 | K140539 | 000 |
| 30680651426209 | K140539 | 000 |
| 10889942310692 | K140539 | 000 |
| 30680651417252 | K140539 | 000 |
| 30680651417276 | K140539 | 000 |
| 30680651417399 | K140539 | 000 |
| 30680651417412 | K140539 | 000 |
| 30680651418792 | K140539 | 000 |
| 30680651418822 | K140539 | 000 |
| 30680651419331 | K140539 | 000 |
| 10889942277995 | K140539 | 000 |
| 10889942046867 | K140539 | 000 |
| 30680651426216 | K140539 | 000 |
| 30680651439384 | K140539 | 000 |
| 30680651439391 | K140539 | 000 |
| 30680651439407 | K140539 | 000 |
| 30680651439421 | K140539 | 000 |
| 30680651417405 | K140539 | 000 |
| 30680651436239 | K140539 | 000 |
| 30680651439414 | K140539 | 000 |
| 30680651417221 | K140539 | 000 |