Stretchease

Primary DI
10850015524001
Brand
Stretchease
Company
THOMAS SCIENTIFIC, LLC
Model
1159G03-NI
Device description
Stretchease Powder-Free Nitrile Examination Gloves, Size Ex-Small, 1000/CS
Published
2022-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141590000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141590000EMG BLUE NITRILE MEDICAL EXAMINATION GLOVE POWDER FREEEco Medi Glove Sdn. Bhd.2014-09-03LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850015524001PackageGS110In Commercial Distribution
00850015524004PrimaryGS10
00850015524820Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001552400110850015524001
00850015524004008500155240048500155240040850015524004
00850015524820008500155248208500155248200850015524820

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA 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
080887713
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
00850015524004Stretchease1159G03-NI2022-04-08
00850015524011Stretchease1159G04-NI2022-04-08
00850015524028Stretchease1159G05-NI2022-04-08
00850015524035Stretchease1159G06-NI2022-04-08
00850015524042Stretchease1159G07-NI2022-04-08
00850015524417Stretchease1159G-SAMPLE2022-04-08
00850015524844Stretchease1159G13-NI2022-04-08
10850015524018Stretchease1159G04-NI2022-04-08
10850015524025Stretchease1159G05-NI2022-04-08
10850015524032Stretchease1159G06-NI2022-04-08
10850015524049Stretchease1159G07-NI2022-04-08
10850015524414Stretchease1159G-SAMPLE2022-04-08
30850015524043Stretchease1159G13-NI2022-04-08

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