FDA.report

MICROFLEX

Primary DI
00769799091193
Brand
MICROFLEX
Company
Ansell Healthcare Product
Model
SY-911-L
Catalog number
SY-911-L
Device description
MICROFLEX SY-911 SYNETRON SIZE L (8.5-9.0), Latex Powder-Free Examination Glove
Published
2022-03-17
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

Related Records

Contact Domains

Product Codes

CodeName
LYYLatex Patient Examination Glove

Product Code Classifications

CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00769799091193PackageGS110In Commercial Distribution
00769799091148PrimaryGS10
00071483003895Unit of UseGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00769799091193140076979909119307697990911930769799091193Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.
00769799091148140076979909114807697990911480769799091148Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.
00071483003895140007148300389500714830038950071483003895Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
775-746-6600jacob.ramirez@ansell.com

Regulatory Flags

DUNS number
111267330
Device count
50
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
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

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20076490748658KIMTECH55090550902025-07-03
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20076490754888KIMTECH50706507062025-07-03

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