FDA.reportPublic FDA data

Layer4

Primary DI
00850064227192
Brand
Layer4
Company
Usa Scientific, Inc.
Model
3925-5500
Catalog number
3925-5500
Device description
Layer4 RapidDon Nitrile Exam Gloves X-Large 230 per Box
Published
2024-05-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102790000POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUGPerusahaan Getah Asas Sdn. Bhd.2010-11-29LZC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850064227192PackageGS110In Commercial Distribution
00850064227185PrimaryGS10
10850064227182Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850064227192008500642271928500642271920850064227192
00850064227185008500642271858500642271850850064227185
1085006422718210850064227182

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
352-237-6288info@usascientific.com

Regulatory Flags#

DUNS number
106947237
Device count
230
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
00850064227017Layer43915-11003915-11002024-05-07
00850064227024Layer43915-22003915-22002024-05-07
00850064227048Layer43915-33003915-33002024-05-07
00850064227062Layer43915-44003915-44002024-05-07
00850064227086Layer43915-55003915-55002024-05-07
00850064227109Layer43925-11003925-11002024-05-07
00850064227123Layer43925-22003925-22002024-05-07
00850064227147Layer43925-33003925-33002024-05-07
00850064227161Layer43925-44003925-44002024-05-07
00850064227185Layer43925-55003925-55002024-05-07
00850064227000Layer43915-11003915-11002024-05-07
00850064227031Layer43915-22003915-22002024-05-07
00850064227055Layer43915-33003915-33002024-05-07
00850064227079Layer43915-44003915-44002024-05-07
00850064227093Layer43915-55003915-55002024-05-07
00850064227116Layer43925-11003925-11002024-05-07
00850064227130Layer43925-22003925-22002024-05-07
00850064227154Layer43925-33003925-33002024-05-07
10850064227168Layer43925-44003925-44002024-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557919Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557940Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557971Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570558008Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557377Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557407Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557438Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557469Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557490Sempermed 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