CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA

• K Number: K050532
• Device Name: CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA
• Manufacturer: SPI GLOVES SDN. BHD.
• Date Cleared: 2005-04-14 ( 43 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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

Device Description

Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.

AI/ML Overview

The provided medical device is the "Chlorinated Powder Free Latex Examination Gloves" manufactured by SPI Gloves Sdn. Bhd. It is a Class I device regulated under 21 CFR 880.6250 (Latex Patient Examination Glove) with product code LYY.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Chlorinated Powder Free Latex Examination Gloves are based on meeting ASTM D3578-01a2 (or D3578-01a52, as both appear in the document for the same standard) and FDA requirements, including water leak test and minimum powder residual content.

Test	Acceptance Criteria (ASTM D3578-01a2/a52 & FDA)	Reported Device Performance (Chlorinated Powder Free Latex Exam Gloves)
1. Watertightness (1000 ml)	Pass AQL=2.5%	Pass AQL=2.5%
2. Length (mm) - All Sizes	Min 230	240 mm minimum for all sizes
3. Palm Width (mm) - XS	-	< 80 mm
3. Palm Width (mm) - S	80 +/- 10	85 +/- 3 mm
3. Palm Width (mm) - M	95 +/- 10	95 +/- 3 mm
3. Palm Width (mm) - L	111 +/- 10	105 +/- 3 mm
3. Palm Width (mm) - XL	-	> 110 mm
4. Thickness (mm) - Finger (Single Layer)	Min 0.08	0.10 minimum
4. Thickness (mm) - Palm (Single Layer)	Min 0.08	0.10 minimum
5. Physical Properties - Before Aging - Tensile Strength (Mpa)	Min 14.0	*19.9
5. Physical Properties - Before Aging - Ultimate Elongation (%)	Min 650	*835
5. Physical Properties - After Aging - Tensile Strength (Mpa)	Min 14.0	*16.5
5. Physical Properties - After Aging - Ultimate Elongation (%)	Min 500	*786
6. Powder Content	Below 2mg / glove (FDA requirement)	Below 2mg / glove
7. Protein Content	-	Below 50 microgram / gram
8. Biocompatibility Test	Pass Primary Dermal Irritation Test, Pass Guinea Pig Sensitization (Buehler) Test	Passed Biocompatibility Tests

Note: The document specifies "ASTM D3578-01a2" in the table heading and "ASTM D3578-01a52" in the general description of the standard. Assuming these refer to the same standard. The asterisk () for physical properties refers to average results obtained from Attachment C, which is not provided in the input.*

Details of the Study Proving Acceptance Criteria

The provided documentation describes the types of tests conducted and their outcomes, but it does not provide a detailed study report that would include specific sample sizes, ground truth establishment, or expert involvement as typically understood for AI/diagnostic device studies.

Based on the available information, here's what can be inferred and what information is missing:

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated for each test. For the "Watertight (1000 ml)" test, the Acceptance Quality Limit (AQL) of 2.5% is mentioned, which implies a sampling plan was used, but the specific sample size (e.g., number of gloves tested) is not given.
• Data Provenance: The tests were performed by the manufacturer, SPI Gloves Sdn. Bhd., in Malaysia. The type of study (e.g., retrospective or prospective) is not explicitly mentioned but these performance tests are typically conducted prospectively on manufactured batches.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This is not applicable in the context of this device and these physical/chemical performance tests. "Ground truth" established by experts is typically for diagnostic devices assessing medical images or clinical data. For examination gloves, the "ground truth" is defined by the objective measurement of physical and chemical properties against established standards (ASTM, FDA).

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

• This is not applicable. Adjudication methods are used to resolve disagreements among human readers/experts in diagnostic studies. For these physical and chemical tests, the results are objective measurements from laboratory testing.

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:

• No, this was not done. This type of study is relevant for AI-powered diagnostic devices, not for examination gloves, which are physical barriers and do not involve human readers interpreting data enhanced by AI.

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

• Not applicable. This device is not an algorithm or AI system, so the concept of standalone performance does not apply.

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

• The "ground truth" for the performance claims of these gloves is defined by established regulatory and international standards (ASTM D3578-01a2/a52 and FDA requirements). For example, a glove is considered "watertight" if it passes the 1000 ml test with an AQL of 2.5%. "Tensile strength" is determined by mechanical testing against a minimum threshold. "Powder content" is determined by chemical analysis against a maximum threshold.

8. The sample size for the training set:

• Not applicable. This device is not an AI or machine learning model, so there is no "training set." The tests are performed on samples from manufacturing batches.

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

• Not applicable, as there is no training set for an AI/ML model.

In summary:

The provided document demonstrates that the "Chlorinated Powder Free Latex Examination Gloves" meet the specified performance criteria based on objective physical and chemical testing against recognized standards (ASTM D3578-01a2/a52) and FDA requirements. The information required for AI/diagnostic device studies (like sample sizes, expert qualifications, adjudication, MRMC studies, or training data details) is not relevant for this type of medical device and is therefore not present in the submission.

Summary

{0}------------------------------------------------

APR 1 4 2005

K050532

SPI GLOVES SDN. BHD. 5, Persiaran Greentown 8, Greentown Business Centre, 3045() Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: [e-mail]

1.0	SMDA 510 (K) SUMMARY
2.0	Submitter	SPI GLOVES SDN. BHD.5, Persiaran Greentown 8,Greentown Business Centre,30450 Ipoh, Perak, Malaysia.
	Tel	(60 5) 322 3200
	Fax	(60 5) 322 2300
	Name of Contact Person	Ms. CHUN CHOOI FONG
	Date of Summary Prepared	February 7, 2005
3.0	Name of Device
	Device Name	Chlorinated Powder Free Latex Examination Gloves
	Common Name	Exam Glove
	Classification Name	Latex Patient Examination Glove

Identification of the Legally Marketed Devices 4.0

Class 1 Latex Patient Examination Glove 80LYY, powder free that mects all the Class - Datex Patting Standard D3578-01a22 and FDA requirements.

5.0 Description of The Device

Class 1 Latex Patient Examination Glove 80LYY, powder free that meets all the requirements of ASTM Standard D3578-01a52 and FDA Water Leak Test.

The Intended Use of Glove 6.0

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

{1}------------------------------------------------

SPI GLOVES SDN. BHD.

5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. c-mail: [e-mail]

7. Summary of Performance Data:

Performance data of gloves based on ASTM D3578-01a52 and FDA 1000 ml watertight test.

TEST	ASTM D3578-01a2	CHLORINATED POWDER FREELATEX EXAM GLOVES
1. Watertight (1000 ml)	G 1AQL=2.5%	Pass GlAQL=2.5%
2. Length (mm)Size XSSMLXL	Min 230Min 230Min 230Min 230Min 230	240 mm minimum forall sizes
3. Palm width (mm)Size XSSMLXL	-80 +/- 1095 +/- 10111 +/- 10-	<80 mm85 +/- 3 mm95 +/- 3 mm105 +/- 3 mm>110 mm
4. Thickness (mm)(Single Layer)FingerPalm	Min 0.08Min 0.08	0.10 minimum0.10 minimum
5. Physical PropertiesBefore AgingTensile Strength (Mpa)Ultimate Elongation (%)	Min 14.0Min 650	*19.9*835
After AgingTensile Strength (Mpa)Ultimate Elongation (%)	Min 14.0Min 500	*16.5*786
6. Powder Content	-	Below 2mg / glove
7. Protein Content	-	Below 50 microgram / gram

• The average results obtain from Attachment C.

{2}------------------------------------------------

SPI GLOVES SDN. BHD.

5, Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak Darul Ridzuan, Malaysia. e-mail: [e-mail]

• The performance data of the glove as showed above meet the ASTM D3578-01a" 8. Standard and FDA's requirement. Powder content is below 2mg per glove, which meet the FDA Requirements.
• The Biocompatibility Test consists of Primary Dermal Irritation Test and Guinea 9. Pig Sensitization (Buehler) test. The gloves pass the Biocompatibility Tests.
• 10. Conclusion

We concluded that the Chlorinated Powder Free Latex Examination Gloves meet the below specifications:

• ASTM D3578-01a52 Standard -
• FDA pinhole requirements -
• FDA minimum powder residual content -

Page 3 of 3 ATTACHMENT N

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" printed around the edge. Inside the circle is a stylized image of three overlapping lines that resemble an abstract human figure.

Public Health Service

APR 1 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Chun Chooi Fong Quality Management System Manager SPI Gloves SND. BHD. 5. Persiaran Greentown 8, Greentown Business Centre, 30450 Ipoh, Perak, Darul Ridzuan MALAYSIA

Re: K050532

Trade/Device Name: Chlorinated Powder Free Latex Examination Gloves with Protein Labeling Claim (Contains 50 Micrograms or Less of Total Water Extractable Protein Per Gram) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: February 28, 2005 Received: March 2, 2005

Dear Ms. Chooi Fong:

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 Eederal Register.

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Page 2 - Ms. Chooi Fong

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 (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.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chia-Lin, Ph.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 STATEMENT

: SPI Gloves Sdn. Bhd. Applicant

510(K) Number: K050532

Device Name : Chlorinated Powder Free Latex Examination Gloves With Protein Labeling Claim (Contains 50 micrograms or less of Total Water Extractable Protein per Gram)

Indication For Use:

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

.............................................................................................................................................................................. Concurrence of CDRH Office of Device Evaluation (ODC)

Prescription Use: 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OR Over-The-Counter X Per 21 CFR 80.109 Anesth May 5 Hogy, General Hospital, Con Control. Denial Devices Number K050532

Page 5

:

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:

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.