Blue Powdered Latex Examination Gloves, Non-sterile is a disposable medical device made from natural rubber latex compound. It is intended to be worn on the hands as barrier against potentially infectious materials and other contamination.

Device Description

Latex Patient Examination Gloves, LYY, Powdered

AI/ML Overview

1. A table of acceptance criteria and the reported device performance

TEST	REQUIREMENT	IN-HOUSE QUALITY PERFORMANCE
1. Water Leak Test (1000ml)	GII, AQL 2.5	Pass GI, AQL 1.5
2. Length (mm)
Size: XS	Min. 220	Minimum 290 mm for all sizes
S	Min. 230	Minimum 290 mm for all sizes
M	Min 230	Minimum 290 mm for all sizes
L	Min 230	Minimum 290 mm for all sizes
XL	-	Minimum 290 mm for all sizes
3 Palm Width (mm)
Size : XS	$70\pm10$	75-78
S	$80\pm10$	82-86
M	$90\pm10$	92-95
L	$100\pm10$	103-109
XL	-	111-115
4. Thickness (mm) (Single layer)
Finger	Min 0.08	Min 0.10
Palm	Min 0.08	Min 0.10
5. Physical Properties
Before Ageing
Tensile Strength (MPa)	Min. 14	Min 18
Ultimate Elongation (%)	Min 700	Min 700
After Ageing
Tensile Strength (MPa)	Min.14	Min. 14
Ultimate Elongation (%)	500	500
6. Powder Content	ASTM 6124	Below 10.0 mg/glove
7. Protein Content	ASTM 5712	Below 200 µg/dm²

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The data provenance and sample size for the test set are not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable. The study is about the quality performance of examination gloves, not an AI diagnostic device requiring expert interpretation of medical images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. The study is about the quality performance of examination gloves, not an AI diagnostic device requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance of the gloves is based on industry standards and regulatory requirements, specifically:

ASTM D 3578-01 Standard
FDA's pinhole requirement
FDA's minimum powder residual content
CMDR requirement
CGSB requirement
Label Claim of 200 µg/dm² or less of total water extractable protein content (based on ASTM 5712)
Biocompatibility Test (Primary Dermal Irritation Study and Dermal Sensitization Study).

8. The sample size for the training set

Not applicable. The provided document concerns the physical and chemical properties of examination gloves, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. The provided document concerns the physical and chemical properties of examination gloves, not an AI model.

Summary

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K062526

17.0 SMDA 510(K) SUMMARY

APR 1 3 2007

1.	Applicant	:	MULTISAFE SDN. BHDLot 764, Bidor Industrial Estates,35500 Bidor,Perak Darul Ridzuan,Malaysia.
	Tel No.	:	605-4348269
	Fax No	:	605-4348266
	Name of Contact Person	:	1. Mr. Abd Hadi bin Husin2. Ms. Rosnani Binti Hassan Besari
	Date of Summary Prepared	:	28th February 2007
2.	Name of Device
	Trade Name	:	Blue Powdered Latex ExaminationGlove, Non-Sterile
	Common Name	:	Examination Gloves
	Classification Name	:	Patient Examination Gloves (Class 1 inUS and European markets, Class IIa inCanadian Market)

3. Identification Of the Legally Marketed Devices

Latex Patient Examination Gloves LYY, Powdered that meets all the requirements of FDA, ASTM D 3578, ISO 11193, EN 455 : Part 1, Part 2 and Part 3, CMDR, MDR and CGSB.

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Description Of the Devices 4.

Latex Patient Examination Gloves, LYY, Powdered

5. The Intended Use of Glove

A medical glove is worn on the hands of healthcare and similar personnel as a barrier against potentially infectious materials and other contamination between healthcare and patient's body, fluid, waste or environment.

The Quality performance of the glove are shown in the table above (. meets ASTM D 3578-01 Standard and FDA's requirement
The Biocompatibility Test consists of Primary Dermal Irritation Study 7. And the Dermal Sensitization Study. The gloves pass the Biocompatibility Test.

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Summary of Quality Performance 8.

...

The Quality Performance of gloves based on the requirements stated in item 6.

TEST	REQUIREMENT	IN-HOUSE QUALITYPERFORMANCE
1. Water Leak Test(1000ml)	GII, AQL 2.5	Pass GI, AQL 1.5
2. Length (mm)Size: XS	Min. 220	Minimum 290 mm for allsizes
S	Min. 230
M	Min 230
L	Min 230
XL	-
3 Palm Width (mm)Size : XS	$70\pm10$	75-78
S	$80\pm10$	82-86
M	$90\pm10$	92-95
L	$100\pm10$	103-109
XL	-	111-115
4. Thickness (mm)(Single layer)
Finger	Min 0.08	Min 0.10
Palm	Min 0.08	Min 0.10
5. PhysicalProperties
Before Ageing
Tensile Strength (MPa)	Min. 14	Min 18
Ultimate Elongation (%)	Min 700	Min 700
After Ageing
Tensile Strength (MPa)	Min.14	Min. 14
Ultimate Elongation (%)	500	500
6. Powder Content	ASTM 6124	Below 10.0 mg/glove
7. Protein Content	ASTM 5712	Below 200 µg/dm²

. . .

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Conclusion 9.

We concluded that the Blue Powdered Latex Examination Gloves, Protein Content Labeling (200 µg/dm2 or less), Non-Sterile meets:

ASTM D3578 Standard
· FDA pin hole requirement
FDA minimum powder residual content
· CMDR requirement
CGSB requirement
· Label Claim of 200 µg/dm2 or less of total water extractable protein content

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......

. Comparison table and discussion of the similarities and difference of Blue Powdered Latex :amination Gloves (Non-Sterile) compared to Multisafe Powdered Latex Examination Gloves, (Non-.. erile).

No	Description	Requirement	510K No
			K993811	K062526
1	Water Tight Test(1000ml)	GII, AQL 2.5	Pass GI, AQL 1.0	Pass GI, AQL 1.5
2	Dimension Test	Min. 290 (Long Glove)Min. 230 (Short Glove)	Min 230 for all sizes	Min 290 for all sizes
3	Palm Width (mm)	XS : 70 +/- 10S : 80 +/- 10M : 90 +/- 10L :100 +/- 10	Meet the specification	Meet the specification
4	Thickness (mm)i) Fingerii) Palm	Min. 0.08Min. 0.08	Meet the specification	Meet the specification
5	Physical Properties (BeforeAging)i) Tensile Strength(Mpa)	Min 14	Min 18	Min. 18
	ii) UltimateElongation (%)	Min. 700	Min. 700	Min. 700
	Physical Properties(After Aging)
	i) Tensile Strength(Mpa)	Min. 14	Min. 14	Min. 14
	ii) UltimateElongation (%)	Min. 500	Min. 500	Min. 500
6	Powder Content	ASTM 6124	Meet the specification	Below 10.0mg/glove
7	Protein Content	ASTM 5712	Meet the specification	Below 200 µg/dm²
8	Biocompatibility Testi) Primary SkinIrritation	No Animal Irritation	Yes	Yes
	ii) DermalSensitization Assay(Animal Study)	No Animal Irritation	Yes	Yes
9	Colour Extraction	Others	Normal CreamyWhite	Blue Colour
10	Ingredienta) Latexb) Acceleratorsc) Antioxidantd) Curing Agente) Activator	Natural Rubber latexZDBCZDECSulphurZinc Oxide	√	√
f) Dispersing Agentg) Filler / Pigmenth) Donning Powderi) Pigment	TamolTitanium DioxideModified Corn StarchFlexobrite Blue
		√√√X	√√√√

1 ୧

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Conclusion :

125

e Blue Powdered Latex Examination Gloves (Non-Sterile) is similar with Multisafe Powdered Latex Examination Gloves (Non-Sterile) except the dimension of length and colour extraction (

MULTISAFE SDN. BHDA

R ABD HADI HUSIN (Plant Mahager)

। ।

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 3 2007

Mr. Abd Hadi Bin Husin Quality Management Representative/Plant Manager Multisafe Sdn Bhd Lot 764, Bidor Industrial Estate 35500 Bidor Perak Darul Ridzuan MALAYSIA

Re: K062526

Trade/Device Name: Blue Powdered Latex Examination Gloves, Non-Sterile Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: February 14, 2007 Received: March 19, 2007

Dear Mr. Husin:

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 (for the indications for use stated in the enclosure) 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Husin

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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sylitte Y. Micham Om.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K062526

Device Name: Blue powdered latex Examination Gloves, Non-sterile

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Stales H.M. Murphy, bo

(K) Number K 062526

Page 1 of 1

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.