FDA.reportPublic FDA data

SLATE

Primary DI
00850040723076
Brand
SLATE
Company
American Nitrile Operations, LLC
Model
ANSL453
Catalog number
ANSL453
Device description
SLATE SIZE M, Nitrile Powder-Free, Chemo and Fentanyl Resistant Examination Glove
Published
2023-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCPatient Examination Glove, Specialty
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220825000Sapphire Pro Powder-Free Royal Blue Nitrile Exam GlovesAmerican Nitrile Operations, LLC2022-07-08LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850040723229PackageGS110In Commercial Distribution
00850040723076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850040723229008500407232298500407232290850040723229
00850040723076008500407230768500407230760850040723076

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.

Contacts#

Phone, Email table
PhoneEmail
614-600-2655xx@xx.xx

Regulatory Flags#

DUNS number
118378851
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040723052STEELFLEXANST356ANST3562024-02-14
00850040723090SLATEANSL455ANSL4552024-02-14
00850040723151STEELFLEXANST355ANST3552024-02-14
00850040723311SLATEANSL456ANSL4562024-02-14
00850040723250STEELFLEXANST356ANST3562024-02-14
00850040723243SLATEANSL455ANSL4552024-02-14
00850040723106SLATEANSL451ANSL4512024-02-14
00850040723113STEELFLEXANST351ANST3512024-02-14
00850040723304STEELFLEXANST355ANST3552024-02-14
00850040723328SLATEANSL456ANSL4562024-02-14
00850040723083SLATEANSL454ANSL4542023-02-17
00850040723120STEELFLEXANST352ANST3522023-02-17
00850040723137STEELFLEXANST353ANST3532023-02-17
00850040723144STEELFLEXANST354ANST3542023-02-17
00850040723069SLATEANSL452ANSL4522023-02-17
00850040723229SLATEANSL453ANSL4532023-02-17
00850040723236SLATEANSL454ANSL4542023-02-17
00850040723274STEELFLEXANST352ANST3522023-02-17
00850040723281STEELFLEXANST353ANST3532023-02-17
00850040723298STEELFLEXANST354ANST3542023-02-17

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Primary DI, Brand, Company table
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09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202196mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209249Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209263Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209287Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209300Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570536686Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536716Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536723Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536747Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536754Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
08994452290022Nitrile Examination Gloves Powder FreePT. SINTONG UNIGOLDEN GLOVELZC2024-02-26