A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)

• K Number: K153744
• Device Name: A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)
• Manufacturer: A1 GLOVE SDN BHD
• Date Cleared: 2016-08-04 ( 220 days)
• Product Code: LYY
• Regulation Number: 880.6250

Intended Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm- of Glove or Less of Water Extractable Protein), meets all of the requirements of ASTM D3578:05-2010

Predicate Devices

K112612

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define a standard patient examination glove, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, primarily for protective and hygienic purposes rather than for treating or curing a medical condition.

Diagnostic

No

The device is a patient examination glove, which is used for preventing contamination between patient and examiner and does not perform any diagnostic functions.

SaMD (Software as a Medical Device)

No

The device is a physical patient examination glove, not a software application. The description clearly outlines a tangible product made of latex.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "worn on the examiner's hand to prevent contamination between patient and examiner." This describes a barrier device used for protection, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
• Device Description: The description focuses on the physical properties and standards met by the glove (latex, powder-free, protein content, ASTM standard). This aligns with a medical device used for physical protection.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to gain information about a patient's health status. This glove does not perform such a function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Product codes (comma separated list FDA assigned to the subject device)

LYY

Device Description

Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm- of Glove or Less of Water Extractable Protein), meets all of the requirements of ASTM D3578:05-2010

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Medical purposes, worn on the examiner's hand.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The device was tested against ASTM D3578:05-2010 for Dimensions and Physical Properties, ASTM D5151:06-2011 for Freedom from pin-holes, ASTM D6124:06-2011 for Powder Free Residue, ASTM D5712:10-2010 for Protein Content, and ISO 10993-10:2010 for Biocompatibility (Animal Irritation Test and Dermal Sensitization).
Key results:

• Dimensions: Meet ASTM D3578:05-2010 specifications (Palm Thickness: 0.09 mm, Finger Thickness: 0.11 mm, Length by size S: 240 mm, M: 240 mm, L: 240 mm).
• Physical Properties: Meet ASTM D3578:05-2010 specifications (Tensile Strength Before aging: 22.91 MPa, After Aging: 20.98 MPa; Elongation at Break Before aging: 850 mm, After aging: 820 mm).
• Freedom from pin-holes: Meet AQL 1.5.
• Powder Free Residue: Below 2mg/glove.
• Protein Content: Below 50ug/dm².
• Biocompatibility: Not an irritant and not a sensitizer.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K112612

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 6, 2016

A1 Glove Sdn. Bhd. Mr. John Phan Lot 3726, Kawasan Perindustrian Nilai, Mukim Setul Nilai. Negeri Sembilan 71900 MALAYSIA

Re: K153744

Trade/Device Name: A1 Brand Powder Free Patient Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Patient examination glove Regulatory Class: Class I Product Code: LYY Dated: July 13, 2016 Received: July 13, 2016

Dear: John Phan

This letter corrects our substantially equivalent letter of July 13, 2016.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Susan Runno DDS, MA

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K 153744

Device Name

A 1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contain 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)

Indications for Use (Describe)

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

pe of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

A1 GLOVE SDN. BHD.

Date: 8th July 2016

510k number: K 153744

1.01 Submitter:

Name	: A1 Glove Sdn. Bhd.
Address	: Lot 3726, Kawasan Perindustrian Nilai,
Mukim Setul, Daerah Seremban, Malaysia
Country	: Malaysia
Phone No.	: [phone]

1.02 Contact Person:

Contact	: Mr. John Phan
E-mail	: [e-mail]
Telephone No.	: [phone]
Fax No.	: [phone]

1.03 Name of Device:

Trade Name	: A1 Glove Powder Free Latex Patient Examination Gloves with
	Protein Content Labeling Claim (Contain 50 Micrograms
	per dm² of glove or Less of Water Extractable Protein)
Common Name	: Patient Examination Gloves
Classification Name	: Patient Examination Glove
Product Code	: LYY

1.04 Identification of The Legally Marketed Device:

Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contain 50 Micrograms per dm of Glove or Less of Water Extractable Protein), LYY, meets all of the requirements of ASTM D-3578 Standard Specification of Latex Examination Gloves for Medical Application which equivalent to legally marketed device of K112612.

Predicate Device: K112612, Powder Free Latex Patient Examination Glove with Protein Content Labeling Claim (Contains 50 Micrograms per dm of glove or Less of Water Extractable Protein)

1.05 Description of Device

Powder Free Latex Patient Examination Gloves, with Protein Content labeling Claim (Contains 50 Micrograms per dm- of Glove or Less of Water Extractable Protein), meets all of the requirements of ASTM D3578:05-2010

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1.06 Intended use of the device:

A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

1.07 Summary of the Technological Characteristics of the Device

Powder Free Latex Examination Gloves possesses the following technological characteristic (as compared to ASTM or equivalent standard):

| CHARACTERISTICS | STANDARDS | SPECIFICATION | DEVICE PERFORMANCE/
ACTUAL SPECIFICATION |
|------------------------|---------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Dimensions | ASTM D3578:05-2010 | Thickness
Palm : min 0.08mm
Finger: min 0.08mm | Meet.
Palm Thickness: 0.09 mm
Finger Thickness: 0.11 mm |
| | | Length (by size)
S : min 220
M : min 220
L : min 230 | Length (by size)
S : 240 mm
M : 240 mm
L : 240 mm |
| Physical Properties | ASTM D3578:05-2010
ASTM D412:06
ASTM D573:04-2010 | Tensile Strength (MPa)
Before aging : Min 18 MPa
After aging : Min 14 MPa | Meet
Tensile Strength (MPa)
Before aging : 22.91 MPa
After Aging : 20.98 MPa |
| | | Elongation at Break (%)
Before aging : Min 650mm
After aging: Min 500mm | Elongation at Break (%)
Before aging : 850 mm
After aging : 820 mm |
| Freedom from pin-holes | ASTM D5151:06-2011 | AQL 1.5 | Meet |
| Powder Free Residue | ASTM D6124:06-2011 | Below 2mg/glove | Meet |
| Protein Content | ASTM D5712:10-2010 | Below 50ug/dm² | Meet |
| Biocompatibility | Animal Irritation Test
(ISO 10993-10:2010) | Under the conditions
tested, the subject glove
was not an irritant. | Under the conditions tested, the
subject glove was not an
irritant. |
| | Dermal Sensitization
(ISO 10993-10:2010) | Under the condition tested,
the subject glove was not a
sensitizer. | Under the condition tested, the
subject glove was not a
sensitizer. |

1.08 Substantial Equivalent based on Assessment of Non-Clinical Performance Data The performance test data of non-clinical tests that support a determination of substantial equivalence is the same as shown on the table above.

1.09 Substantial Equivalent based on Assessment of Clinical Performance Data Clinical data for the subject glove is not needed.

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1.10 Substantial Equivalence Comparison
Characteristic &
Parameters	Predicate Device	Proposed Device	Specification	Substantial
Equivalence
	K112612, Powder Free Latex
Patient Examination Glove
with Protein Content Labeling
Claim (Contains 50
Micrograms per dm² of glove
or Less of Water Extractable
Protein)	A1 Glove Powder Free Latex
Patient Examination Gloves
with Protein Content Labeling
Claim (Contain 50 Micrograms
per dm² of glove or Less of
Water Extractable Protein)		SE
Product Code	LYY	LYY		SE
FDA Device Class	Class I	Class I		SE
Intended Use	A patient examination gloves is
a disposable device intended
for medical purposes that is
worn on the examiner's hand to
prevent contamination between
patient and examiner.	A patient examination glove is
a disposable device intended
for medical purposes that is
worn on the examiner's hand to
prevent contamination between
patient and examiner.		SE
Material	Natural Rubber Latex	Natural Rubber Latex		SE
Dimensions	Meets ASTM D3578	Meets ASTM D3578:05-2010	Thickness
Palm : min 0.08mm
Finger : min 0.08mm

Length (by size)
S : min 220
M : min 220
L : min 230 | SE |
| Physical Properties | Meets ASTM D3578 | Meets ASTM D3578:05-2010 | Tensile Strength (MPa)
Before aging : Min 18 MPa
After aging : Min 14 MPa

Elongation at Break (%)
Before aging : Min 650mm
After aging: Min 500mm | SE |
| Freedom from Pin Holes -
ASTM D5151 | Meets ASTM D5151 | Meets ASTM D5151:06:2011 | AQL 1.5 | SE |
| Protein Content-
ASTM D5712 | Meets ASTM D5712 | Meets ASTM D5712:10-2010 | Below 50ug/dm² | SE |
| Skin Irritation
ISO 10993-10:2002 | Under the condition tested, the
subject glove was not an
irritant. | Under the condition tested, the
subject glove was not an
irritant. | Under the condition tested,
the subject glove was not an
irritant. | SE |
| Dermal sensitization
ISO 10993-10:2002 | Under the condition tested, the
subject glove was not a
sensitizer. | Under the condition tested, the
subject glove was not a
sensitizer. | Under the condition tested,
the subject glove was not a
sensitizer. | SE |

1.10 Substantial Equivalence Comparison

Table 1.10. Substantial Equivalence Comparison

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1.11 Conclusion

The conclusion drawn from the non-clinical testing demonstrates that the subject glove is as safe, as effective, and performs as well as the legally marketed predicate device, K112612.