FDA.reportPublic FDA data

PurCel Labs XL 4 MIL Black Exam Gloves

Primary DI
00810143550672
Brand
PurCel Labs XL 4 MIL Black Exam Gloves
Company
Purcel Labs LLC
Model
1403-100
Device description
Black Nitrile Exam Gloves, Size XL, 4 MIL, Medical and Food Grade, Ambidextrous, Latex-Free, Powder-Free, Single Use, Non-Sterile, (100/Box).
Published
2023-08-15
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
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123869000
K133307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123869000POWDER-FREE NITRILE PATIENT EXAMINATION GLOVESDehai (Shandong) Medical Gloves, Co., Ltd.2013-02-28LZA
K133307000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143550672PackageGS110In Commercial Distribution
00810143550689PackageGS12In Commercial Distribution
00810143550665PrimaryGS10
10810143550662Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143550672008101435506728101435506720810143550672
00810143550689008101435506898101435506890810143550689
00810143550665008101435506658101435506650810143550665
1081014355066210810143550662

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
127672531
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143550221PurCel Labs Small Vinyl Exam Gloves1200-1502023-08-04
00810143550252PurCel Labs Medium Vinyl Exam Gloves1201-1502023-08-04
00810143550283PurCel Labs Large Vinyl Exam Gloves1202-1502023-08-04
00810143550313PurCel Labs XL Vinyl Exam Gloves1203-1502023-08-04
00810143550573PurCel Labs Small 4 MIL Black Exam Gloves1400-1002023-08-15
00810143550603PurCel Labs Medium 4 MIL Black Exam Gloves1401-1002023-08-15
00810143550634PurCel Labs Large 4 MIL Black Exam Gloves1402-1002023-08-15
00810143550665PurCel Labs XL 4 MIL Black Exam Gloves1403-1002023-08-15
00810143550771PurCel Labs ASTM Level 1 Surgical Masks3000-502023-08-18
00810143550795PurCel Labs Individually Wrapped ASTM Level 1 Surgical Masks3001-502023-08-18
00810143550405 PurCel Labs Safety Insulin Pen Needles (32G x 4mm)1086-1002023-08-08
00810143550429 PurCel Labs Safety Insulin Pen Needles (31G x 5mm)1087-1002023-08-08
00810143550443PurCel Labs Safety Insulin Pen Needles (30G x 6mm)1088-1002023-08-08
10810143550402 PurCel Labs Safety Insulin Pen Needles (32G x 4mm)1086-1002023-08-08
00810143550481 PurCel Labs Safety Insulin Pen Needles (31G x 5mm)1087-1002023-08-08
00810143550504PurCel Labs Safety Insulin Pen Needles (30G x 6mm)1088-1002023-08-08
00810143550788PurCel Labs ASTM Level 1 Surgical Masks3000-502023-08-18
00810143550801PurCel Labs Individually Wrapped ASTM Level 1 Surgical Masks3001-502023-08-18
00810143550580PurCel Labs Small 4 MIL Black Exam Gloves1400-1002023-08-15
00810143550610PurCel Labs Medium 4 MIL Black Exam Gloves1401-1002023-08-15

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Primary DI, Brand, Company table
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