FDA 510 (k) Sterile Surgical Gown
REF.NO:87.00X.01-88.00X.01-89.00X.01
Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) is a sterile, single-use surgical gown intended to be protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate materials. It has been tested and is classified as Level 4 in the critical zones per AAMI Standard PB70: Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use In Healthcare Facilities.
| REFERENCE CODE | PRODUCT NAME | SIZE |
| 87.001.01 | Sterile Triplex Surgical Gown with 1 hand towel | S |
| 87.002.01 | Sterile Triplex Surgical Gown with 1 hand towel | M |
| 87.003.01 | Sterile Triplex Surgical Gown with 1 hand towel | L |
| 87.004.01 | Sterile Triplex Surgical Gown with 1 hand towel | XL |
| 87.005.01 | Sterile Triplex Surgical Gown with 1 hand towel | XXL |
| 87.006.01 | Sterile Triplex Surgical Gown with 1 hand towel | XXXL |
| 88.001.01 | Sterile Triplex Surgical Gown with 2 hand towels | S |
| 88.002.01 | Sterile Triplex Surgical Gown with 2 hand towels | M |
| 88.003.01 | Sterile Triplex Surgical Gown with 2 hand towels | L |
| 88.004.01 | Sterile Triplex Surgical Gown with 2 hand towels | XL |
| 88.005.01 | Sterile Triplex Surgical Gown with 2 hand towels | XXL |
| 88.006.01 | Sterile Triplex Surgical Gown with 2 hand towels | XXXL |
| 89.001.01 | Sterile Triplex Surgical Gown | S |
| 89.002.01 | Sterile Triplex Surgical Gown | M |
| 89.003.01 | Sterile Triplex Surgical Gown | L |
| 89.004.01 | Sterile Triplex Surgical Gown | XL |
| 89.005.01 | Sterile Triplex Surgical Gown | XXL |
| 89.006.01 | Sterile Triplex Surgical Gown | XXXL |