The surgeon's glove is a device made of natural rubber intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Device Description

Class II natural rubber latex surgeon's glove, 79 KGO, powdered with absorbable dusting powder. It meets all of the requirements of ASTM standard D3577-99.

AI/ML Overview

This document describes the acceptance criteria and performance data for WRP Specialty Products Sdn Bhd's DERMAGRIP POWDERED LATEX SURGICAL GLOVE, STERILE (K993215).

1. Table of Acceptance Criteria and Reported Device Performance

Quality Requirement	Acceptance Criteria Before Aging	Reported Device Performance Before Aging	Acceptance Criteria After Aging	Reported Device Performance After Aging	Unit
Tensile Strength	Min 24	Not explicitly stated (implied to meet)	Min 18	Not explicitly stated (implied to meet)	MPa
Ultimate Elongation	Min 750	Not explicitly stated (implied to meet)	Min 560	Not explicitly stated (implied to meet)	%
Stress at 500% Elongation	Max 5.5	Not explicitly stated (implied to meet)	Not Applicable	Not Applicable	MPa

Powder Weight Criteria:

Powder Location	Acceptance Criteria	Reported Device Performance (Size 7 ½)	Unit
Internal	0.5 - 1.5%	1.41	%
External (Max)	1.0%	0.96	%
Powder Weight*	Not specified	204.7	mg/glove
External Powder Weight	Not specified	140.0	mg/glove

Note: The document states "WRP Specialty Products Sdn. Bhd. SIZE 7½ ACTUAL POWDER WEIGHT mg/glove" for 204.7, and "External (Max) : 1.0% 0.96 140.0" implying 140.0 mg/glove for external powder. The "Internal" powder is given as 1.41% and 204.7 mg/glove. This implies that 204.7 mg is the internal powder weight for a Size 7 1/2 glove to be 1.41%, and 140.0 mg is the external powder weight for a Size 7 1/2 glove to be 0.96%.*

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

Sample Size for Physical Requirement Test: 13 pieces per batch.
Batch Size: 300,000 pairs (based on one consignment quantity).
Data Provenance: Not explicitly stated, but given the company's location (Malaysia), the testing was likely conducted in Malaysia. The document does not specify if the data is retrospective or prospective, but for product quality control, it would typically be prospective for each batch produced.
Sample Size for Powder Weight: Average over eight (8) pieces.

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

Not applicable. The ground truth for this device is established by objective physical and chemical measurements (tensile strength, elongation, powder weight) against specified standards (ASTM D3577-99, ASTM D412-87). No human expert interpretation of results is mentioned beyond standard laboratory practice.

4. Adjudication Method for the Test Set

The adjudication method for the physical requirement test is based on an Acceptance Quality Limit (AQL) system in accordance with ISO 2859/ANSI/ASQC Z1.4.

AQL: 4.0
Acceptance Criteria: 1 pc (meaning 1 or fewer defective pieces in the sample of 13)
Rejection Criteria: 2 pcs (meaning 2 or more defective pieces in the sample of 13)

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 a medical device (surgical glove) for which AI assistance for human readers is not relevant. The testing focuses on the physical properties and sterility of the glove.

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

Not applicable. This is a physical medical device; there is no algorithm involved.

7. The Type of Ground Truth Used

The ground truth used is based on established industry standards and objective physical measurements:

ASTM D 3577-99: Standard Specification for Rubber SURGICAL Gloves.
ASTM D 412-87: Standard Test Methods for Rubber Properties in Tension.
ISO 2859 / ANSI/ASQC Z1.4: Sampling Procedures and Tables for Inspection by Attributes.
FDA watertight test requirements (mentioned in Attachment 7).

The ground truth for physical properties (Tensile Strength, Ultimate Elongation, Stress at 500% Elongation) and powder weight is derived from these standardized test methods and the acceptance criteria defined within them or by regulatory bodies.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context. Quality is assured by testing samples from production batches.

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

Not applicable, as there is no training set for a physical medical device.

Summary

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DFC - 2 1999

Image /page/0/Picture/4 description: The image shows the logo for WRP. The logo consists of the letters "WRP" in a bold, sans-serif font, with the letters in white and set against a black, rounded rectangle. To the right of the logo is the text "WRP Spec" in a similar font, but without the black background. The text is also in black.

WRP Specialty Products Sdn Bhd

になると、とて

Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi, 43900 Sepang. Selangor Darul Ehsan, MALAYSIA

TEL +60-3-846 2055 FAX +60-3-846 1437 URL www.wrpwarld.com

ATTACHMENT 3

K 9932215

CONTACT PERSON : S.K.OOI

510(k) SUMMARY

DERMAGRIP POWDERED LATEX SURGICAL 1. Trade Name : GLOVE, STERILE
Surgeon's Gloves Common Name 2. :
Classification Name Surgeon's Glove 3. :

4. Substantial Equivalence :

Class II natural rubber latex surgeon's glove, 79 KGO, powdered with absorbable dusting powder. It meets all of the requirements of ASTM standard D3577-99.

5. Description of Device :

Class II natural rubber latex surgeon's glove, 79 KGO, powdered with absorbable dusting powder. It meets all of the requirements of ASTM standard D3577-99.

6. Intended Use of Device :

The surgeon's glove is a device made of natural rubber intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Gloves For All Reasons™

mber of the WRP Group of Companies

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SUMMARIZED PROCEDURE OF THE QUALITY ASSURANCE METHODS 2. FOR SURGICAL GLOVES

(2) REFERENCE 2.1
K 993215
a) ASTM D 3577-99 Standard Specification for Rubber SURGICAL Gloves.
b) ASTM D 412-87 Standard Test Methods for Rubber Properties in Tension.
Sampling Procedures and Tables for Inspection by c) ISO 2859 Attributes.
d) ANSI/ASQC Z1.4-1993 Sampling Procedures and Tables for Inspection by Attributes.

2.2 SAMPLING

The gloves are sampled at random from a batch, where every part has an equal chance of being selected. The samples are selected and inspected in accordance with ISO 2859/ ANSI/ASQC Z1.4.

TEST METHODS 2.3

2.3.1 Physical Requirement Test

a) The tensile physical properties are determined as described in ASTM D412 using Type C dumb bell test pieces. Test pieces are evaluated to conform to physical requirement on before and after accelerated aging.
b) The accelerated aging is conducted by subjecting the test piece to a temperature of 100 ℃ ± 2 ℃ for 22 ± 0.3 hours.

c) Quality Requirement

	Before Aging	After Aging
Tensile Strength	Min 24 Mpa	Min 18 MPa
UltimateElongation	Min 750 %	Min 560 %
Stress at 500%Elongation	Max 5.5 Mpa	Not Applicable

d) The inspection level : ANSI/ASQC Z1.4, (S-2)

Batch Size	: 300 000 pairs (based on one consignment quantity)
Sample Size	: 13 pcs
AQL	: 4.0
Accept	: 1 pc
Reject	: 2 pcs

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Finished Powdered Gloves :

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Average Powder Weights on Size 7 ½ Surgical Gloves

WRP Specialty Products Sdn.Bhd.	SIZE 7½ ACTUAL	POWDER WEIGHT*
	(%)	mg/glove
Internal : 0.5 -1.5%	1.41	204.7
External (Max) : 1.0%	0.96	140.0

Average over eight (8) pieces.

ATTACHMENTS

Number	Attached?	Subject
1.	(/) Yes () No	Truthful & Accurate Statement
2.	(/) Yes () No	Indications for Use Statement
3.	(/) Yes () No	510(k) Summary
4.	(/) Yes () No	Summary of Quality Assurance TestingProcedure of Dermagrip Powdered LatexSurgical Glove, Sterile
5.	(/) Yes () No	Label, Labeling and Advertising
6.	(/) Yes () No	Biocompability Test Reports
7.	(/) Yes () No	Device Test Report of Compliance ofDermagrip Powdered Latex Surgical Glove,Sterile according to ASTM D3577-99 and FDAwatertight test requirements.
8.	(/) Yes () No	Validation on Gamma Radiation SterilizationCycle.
9.	(/) Yes () No	Packaging Use to Maintain the Sterility of theGloves.
10.	(/) Yes () No	Absorbable Dusting Powder Specification.
11.	(/) Yes () No	Summary of Glove Physical Properties (refer toAttachment 7, Device Test Report ofCompliance).
12.	() Yes (/) No	Non-USP Powder Information

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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 features a stylized image of a human profile with three overlapping faces, suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image, emphasizing the organization's name and national affiliation. The overall design is simple and professional, conveying a sense of authority and public service.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 1999

Mr. Soo Kang Ooi Manager, Regulatory Affairs/Quality Assurance WRP Specialty Products Sdn. Bhd. Lot 11, Jalan 2, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan, Malaysia

Re : K993215 Powdered Latex Surgical Glove, Sterile Trade Name: Regulatory Class: I Product Code: KGO September 15, 1999 Dated: Received: September 24, 1999

Dear Mr. Ooi:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in

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Page 2 - Mr. Ooi

the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricia Cucurella /loc

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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ATTACHMENT 2

Applicant : WRP Specialty Products Sdn. Bhd.

510(k) Number (if known) :

DERMAGRIP POWDERED LATEX SURGICAL GLOVE, Device Name : STERILE

Indications For Use :

The surgeon's glove is a device made of natural rubber intended to be worn by 1. surgeons and/or operating room personnel to protect a surgical wound from contamination.
Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use OR

Olin S. Lin

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number J

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).