FDA.reportPublic FDA data

HCS

Primary DI
10849027002430
Brand
HCS
Company
DYAD MEDICAL SOURCING, LLC
Model
HCS6607EX
Device description
Chemo Nitrile Exam Gloves with Fentanyl Protection, 3.7 g, Extended Cuff, X-Large
Published
2019-12-31
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

Product Codes#

Code, Name table
CodeName
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849027002430PackageGS110In Commercial Distribution
00849027002433PrimaryGS10
20849027002437Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084902700243010849027002430
00849027002433008490270024338490270024330849027002433
2084902700243720849027002437

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-sterileA non-sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078572603
Device count
150
DM exempt
false
Premarket exempt
false
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849027000149HCSHCS50062017-01-17
00849027000156HCSHCS50072017-01-17
00849027002587HCSHCS5006C2017-01-17
00849027001757HCSHCS11012019-12-31
00849027001764HCSHCS1101C2019-12-31
00849027001771HCSHCS11032019-12-31
00849027001788HCSHCS1103C2019-12-31
00849027001795HCSHCS11042019-12-31
00849027001801HCSHCS11052019-12-31
00849027001818HCSHCS11062019-12-31
00849027002846HCSHCS11022019-12-31
00849027005182HCSHCS11202021-01-31
00849027005199HCSHCS1120C2021-01-31
00849027005205HCSHCS11212021-01-31
00849027005212HCSHCS11222021-01-31
00849027005229HCSHCS1122C2021-01-31
00849027005236HCSHCS11232021-01-31
00849027005243HCSHCS11252021-01-31
00849027001740HCSHCS11002019-12-31
50849027001417HCSHCS3003XL2019-12-31

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