FDA.reportPublic FDA data

Hopkins Medical Products®

Primary DI
00817643021916
Brand
Hopkins Medical Products®
Company
HOPKINS UNIFORM COMPANY
Model
570849-MED
Catalog number
570849-MED
Device description
Powder Free Latex Free Gloves Medium, each
Published
2018-09-28
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYYLatex patient examination glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817643021916PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817643021916008176430219168176430219160817643021916

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)835-1995customerservice@hopkinsmedical.net

Regulatory Flags#

DUNS number
003080678
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817643023071Hopkins Medical Products Handheld Pulse OximeterY Probe5948102022-05-06
10817643020145Hopkins Medical Products®19696196962018-09-28
10817643020534Hopkins Medical Products®6951986951982018-09-27
00817643020148Hopkins Medical Products®19939199392018-09-28
00817643020537Hopkins Medical Products®6951976951972018-10-01
00817643021558Hopkins Medical Products®20705207052018-09-28
00817643021596Hopkins Medical Products®6906066906062018-09-28
00817643021602Hopkins Medical Products®6906076906072018-09-28
00817643021619Hopkins Medical Products®6906166906162018-09-28
00817643021626Hopkins Medical Products®6906176906172018-09-28
00817643021633Hopkins Medical Products®6985456985452018-09-28
00817643021640Hopkins Medical Products®698545LF698545LF2018-09-28
00817643021657Hopkins Medical Products®6985476985472018-09-28
00817643021664Hopkins Medical Products®698547LF698547LF2018-09-28
00817643020254Hopkins Medical Products®34268342682018-09-28
00817643022135Hopkins Medical Products®6102206102202018-09-28
00817643022241Hopkins Medical Products®6153506153502018-09-28
00817643022258Hopkins Medical Products®6200676200672018-09-28
00817643020155Hopkins Medical Products®34203342032018-09-28
00817643020162Hopkins Medical Products®34204342042018-09-28

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