FDA.reportPublic FDA data

PurCel Labs XL Vinyl Exam Gloves

Primary DI
00810143550313
Brand
PurCel Labs XL Vinyl Exam Gloves
Company
Purcel Labs LLC
Model
1203-150
Device description
Clear Vinyl Exam Gloves, Size XL, Medical Grade, Ambidextrous, Latex-Free, Powder-Free, Single Use, Non-Sterile, (150/Box).
Published
2023-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102444000POWDER-FREE VINYL PATIENT EXAMINATION GLOVESZibo Yingbo Medical Products, Inc.2010-11-22LYZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143550320PackageGS110In Commercial Distribution
00810143550337PackageGS12In Commercial Distribution
00810143550313PrimaryGS10
10810143550310Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143550320008101435503208101435503200810143550320
00810143550337008101435503378101435503370810143550337
00810143550313008101435503138101435503130810143550313
1081014355031010810143550310

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.

Storage And Handling#

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

Regulatory Flags#

DUNS number
127672531
Device count
150
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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
00810143550641PurCel Labs Large 4 MIL Black Exam Gloves1402-1002023-08-15

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