- FDA-LISTED CLASS I MEDICAL DEVICE: our medical gowns are listed under Lovepop’s FDA registration #3016856671 as a Class I medical device, which does not require FDA clearance or approval
- 3RD PARTY TESTED AAMI LEVEL 2 GOWN: our gowns are independently tested to exceed at least Level 2 ANSI/AAMI PB70 standards (See "Certificate Of Analysis" PDF link below for test results)
- 100% WATERPROOF PREMIUM QUALITY MATERIAL: all gowns are made from 100% polyethylene, 30 GSM material weight, 70 grams per gown
- FULL COVERAGE PROTECTION: full back coverage, thumb loops keep sleeves in place for gloves to be worn on top, neck and waist tie for security
- UNIVERSAL ONE SIZE FITS MOST: 47.2" Length x 31.5" Width (shoulder-to-shoulder) x 36.2" Sleeves
| Brand | Lovepop |
| FDA Registration | 3016856671 |
| Protection Level | AAMI Level 2 |
| Material | 100% polyethylene |
| Weight | 30 GSM material, 70 grams per gown |
| Size | Universal (one-size-fits-most) |
| Gown Dimensions | 47.2" Length x 31.5" Width (cross shoulder) x 36.2" Sleeve |
| Back Style | Full Back |
| Cuff Style | Thumb Loops |
| Fastening Type | Neck and Waist Ties |
| Usage | Disposable |
| Sterility | Non-sterile |
| Color | Blue |
| FDA Product Code | OEA |
| UNSPSC Code | 42131612 |
| Country of Origin | Vietnam |
CAUTION: This product is not intended for use in a surgical setting or in an environment where significant exposure to bodily liquid or other hazardous fluids may be expected, including where large quantities of liquid droplets or any quantity of aerosols are generated or expected. This product should not be used in the presence of high intensity heat sources or flammable gas.
FDA EUA DISCLAIMER: This product has been authorized by FDA under an Emergency Use Authorization (EUA) for use as PPE in healthcare settings by healthcare personnel (HCP) as they may help protect HCP and/or patients from the transfer of the SARS-CoV-2 virus in low or minimal risk level situations to prevent the spread of COVID-19. This product has not been FDA cleared or approved. This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak, under Section 564(b)(1) of the Act, 21 USC 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner. Please use this product only when other alternatives are not available.