FDA.report

First Aid Only

Primary DI
00738743007191
Brand
First Aid Only
Company
Acme United Corporation
Model
362000
Catalog number
362000
Device description
Gown, medium impervious
Published
2022-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications

CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00738743007191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00738743007191007387430071917387430071910738743007191

GMDN Terms

TermDefinition
Surgical gown, single-useA garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Sterilization Methods

Method

Contacts

PhoneEmail
800 835 2263customerservice@acmeunited.com

Regulatory Flags

DUNS number
001180207
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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00738743961431Elite First Aid96143961432025-06-12
00738743007030First Aid OnlyM284-400M284-4002023-01-06
00092265912617First Aid Only91261912612023-07-21
00092265913898First Aid Only91389913892022-09-09
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00092265913911First Aid Only91391913912022-09-09
00092265913928First Aid Only91392913922022-09-09
00092265913935First Aid Only91393913932022-09-09
00092265913980First Aid Only91398913982022-09-09
00092265914024First Aid Only91402914022022-09-09
00092265914031First Aid Only91403914032022-09-09
00092265914048First Aid Only91404914042022-09-09
00092265914055First Aid Only91405914052022-09-09
00738743002608First Aid Only36693CV36693CV2022-09-09
00738743002721First Aid Only5011715011712022-09-09
00738743006507First Aid OnlyDX0401MDX0401M2022-09-09
00092265913256First Aid Only91325913252022-08-26
00092265913263First Aid Only91326913262022-08-26

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