A powder-free 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.

Device Description

A powder-free 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the "Powderfree Latex Examination Gloves" described in the provided documents:

The documents provided are a 510(k) Summary and an FDA substantially equivalent letter for "Powderfree Latex Examination Gloves" manufactured by PT. Maja Agung Latexindo. This type of regulatory filing demonstrates substantial equivalence to a predicate device, rather than proving performance against novel acceptance criteria through a full-fledged clinical study.

Therefore, the study design and "acceptance criteria" here refer to meeting established industry standards for similar devices and demonstrating equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (from 510(k) Summary)
Dimensions (Length mm (min.))
Small: 240	240
Medium: 240	240
Large: 240	240
X-Large: 240	240
Margin of Error: ± 5	-
Dimensions (Palm Width mm)
Small: 80	80
Medium: 95	95
Large: 105	105
X-Large: 110	110
Margin of Error: ± 10	-
Dimensions (Thickness mm (min.))
Cuff: 0.08	0.08
Palm: 0.10	0.10
Fingertip: 0.10	0.10
Physical Properties (Before Ageing)
Tensile Strength: 18 Mpa (min)	18 Mpa (min)
Ultimate Elongation: 650 % (min.)	650 % (min.)
Physical Properties (After Ageing at 70°C 168 hrs.)
Tensile Strength: 14 Mpa (min)	14 Mpa (min)
Ultimate Elongation: 500 % (min.)	500 % (min.)
Pinhole Requirement	Meets FDA pinhole requirement
Compliance with Standard	Meets or exceeds ASTM D 3578-05ae2 Standard
Labeling Claim	Meets labeling claim

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated in the provided documents. For physical property testing of gloves adhering to ASTM standards, specific sample sizes are typically defined within the ASTM standard (e.g., ASTM D3578-05ae2 for latex examination gloves specifies sampling plans for various tests like dimensions, physical properties, and watertightness).
Data Provenance: The manufacturing location is "Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA". The testing data would originate from the manufacturer's quality control or third-party testing facilities related to their manufacturing process. The data is retrospective, as it refers to tests conducted on manufactured batches to ensure compliance with the standard.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable in the context of this 510(k) submission. The "ground truth" for the performance specifications of these gloves is defined by the ASTM D 3578-05ae2 Standard and FDA's pinhole requirements. These are engineering and performance specifications, not subjective expert interpretations of medical images or outcomes. The "experts" involved would be the engineers and quality control personnel who conducted the tests and verified compliance with the standard.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation). The tests conducted for glove performance (tensile strength, elongation, dimensions, pinhole) are objective measurements against a defined standard.

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 a study involving human readers or AI assistance. It is a device 510(k) submission for examination gloves, which are physical medical devices, not diagnostic software.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm or software device.

7. The Type of Ground Truth Used

The ground truth used is established industry standards and regulatory requirements, specifically:
- ASTM D 3578-05ae2 Standard for Powder-Free Latex Examination Gloves
- FDA pinhole requirement for examination gloves.
- The specifications defined in the 510(k) summary for dimensions and physical properties, which are derived from or meet these standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of this device manufacturing and regulatory submission. The gloves are manufactured and tested against predefined specifications.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device. The specifications for performance (ground truth) were established over time through industry consensus and regulatory guidance, leading to standards like ASTM D 3578-05ae2.

Summary

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JUFACTURE OF LATEX GLOVES

Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA

AUG 2 8 2008

Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180

Page Numbers 1 of 2

"510 (K)" SUMMARY

K081488

(1) Name of applicant
Address

: SIVA PRAKASH, General Manager : PT. Maja Agung Latexindo J1. Utama No. 08, Puji Mulio, Sunggal 20352 North Sumatera - Indonesia Phone No. : 62-61-8459170 Fax No. : 62-61-8459180

Contact person in U.S.A

: Emmy Tjoeng : 909-591-8855 Phone No. : 909-628-6283 Fax No. : emmyt@smcgloves.com Email

(2) Device details
Trade Name	: Powderfree Latex Examination Gloves
Classification Name	: Powderfree Latex Examination Gloves

: 80 LYY (3) Product Code

(4) Equivalent device legally : Class I Examination Gloves 80 LYY marketed meeting ASTM D 3578-05ae2
: A powder-free patient examination glove is a disposable device (5) Intended use intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

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Jin. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG Sumatera Utara - Indonesia

Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180

Page Numbers 2 of 2

(6) Technological characteristic of the gloves.

a. DimensionsSizes	Small	Medium	Large	X-Large
Length mm (min.)	240	240	240	240	± 5
PalmWidth mm	80	95	105	110	± 10
Thickness (min)
1. Cuff mm	0.08	0.08	0.08	0.08
2. Palm mm	0.10	0.10	0.10	0.10
3. Finger Tip mm	0.10	0.10	0.10	0.10
b. Physical Properties
		Before ageing		After ageingat 70°C 168 hrs.
Tensile Strength		: 18 Mpa (min)		14 Mpa (min)
Ultimate Elongation		: 650 % (min.)		500 % (min.)

(7) Performance data is the same as mentioned immediately above.

(8) Clinical date is not needed for gloves or for most devices cleared by the 510 (K) process.
(9) Non-clinical data We certify that our gloves meet or exceed the ASTM D 3578-05ae2 Standard. Meets FDA pin hole requirement. Meets labeling claim.

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Public Health Service

AUG 2 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

PT. Maja Agung Latexindo C/O Ms. Emmy Tjoeng Marketing Director Shamrock Manufacturing Company Incorporated 5445 Daniels Street Chino, California 91710

Re: K081488

Trade/Device Name: Powder Free Latex Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: August 15, 2008 Received: August 22, 2008

Dear Ms. Tjoeng:

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 - Ms. Tjoeng

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Chien-Lung, 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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PT. MAJA AGUNG LATEXINDO

MANUFACTURING OF LATEX GLOVES

Jln. Utama No. 98 PUJI MULIO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA Telp. 62-61 - 8459160 62-61 - 8459170 Fax. 62-61 - 8459180

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ANNEXURE II

INDICATION FOR USE

Applicant	: PT. Maja Agung Latexindo
510(k) Number (if known)	:
Device Name	: Powder Free Latex Examination Gloves
Indication for use	:

A powder-free 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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use X (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)(Division Sign-Off)
Division of Anesthesiology, General HospitalInfection Control, Dental Devices
510(k) Number:	K081488

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.