A 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

Powder Free Black Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250. The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.

AI/ML Overview

Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:

Device: Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Standard / Acceptance Criteria	Reported Device Performance
Sterility Status	ISO11137-1:2006 (Non-Sterile)	Non-Sterile
Dimensions	ASTM D6319-10	Meets
Physical Properties	ASTM D6319-10	Meets
Thickness	ASTM D6319-10	Meets
Powder Free	ASTM D6124-06	Meets (< 2 mg/glove)
Biocompatibility: Primary Skin Irritation	Primary Skin Irritation - ISO 10993-10:2002(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500	Passes (Non Primary Irritant). No erythema or oedema noted on abraded or non-abraded sites at 24±1 hours and 72±1 hours after application. The Primary Irritation Index (PII) of test material was "0".
Biocompatibility: Dermal Sensitization	Dermal Sensitization - ISO 10993-10:2002(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c)(4)	Passes (Not a contact sensitizer). No positive allergic reaction observed during the challenge phase (at 0±2, 24±2 hours and 48±2 hours) in animals treated with the test material and negative control.
Watertight	ASTM D5151-06 (1000ml)	Passes
Intended Use	For medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.	Meets stated intended use.
Material	ASTM D6319-10 (Nitrile)	Nitrile
Color	- (Predicate: Blue)	Black (Note: This is a deviation from the predicate but considered not significant as per the summary)
Texture	- (Finger textured)	Finger textured
Size	Medical Glove Guidance Manual - Labeling	Extra Small, Small, Medium, Large, Extra Large
Single Use	Medical Glove Guidance Manual - Labeling	Single use
Manufacturer	-	WRP Asia Pacific Sdn Bhd

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

The document does not explicitly state specific sample sizes for tests like biocompatibility or watertightness. The performance is reported against ASTM and ISO standards, which typically involve defined sample sizes. For example, ASTM D6319-10 and ASTM D5151-06 would specify the number of gloves to be tested for dimensions, physical properties, and watertightness. However, these specific numbers are not provided in this 510(k) summary.

The data provenance is not explicitly stated as country of origin, but the manufacturer is WRP Asia Pacific Sdn Bhd, located in Malaysia. The testing would presumably have been conducted in accordance with international standards (ASTM, ISO) adopted by the FDA. The text describes non-clinical performance data.

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

This information is not applicable and not provided. The ground truth for this device (examination gloves) is established through adherence to recognized international and national standards (ASTM, ISO, FDA regulations) that specify physical, chemical, and biological performance requirements. There are no "experts" establishing ground truth in the sense of medical diagnosis; it's about meeting engineering and material performance specifications.

4. Adjudication Method for the Test Set:

Not applicable. This device's performance is objectively measured against quantifiable standards, not through subjective human assessment requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted devices where human interpretation is involved. For examination gloves, the performance is assessed through material and physical property testing.

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

Not applicable. "Standalone performance" refers to the performance of an algorithm or AI system without human involvement. This device is a physical medical device (gloves), not a software or AI product.

7. The Type of Ground Truth Used:

The ground truth used is based on International and National Standards Specifications. These include:

ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves for Medical Application)
ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves)
ISO 10993-10:2002(E) (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization)
Consumer Product Safety Commission, Title 16, Chapter II, Part 1500 (related to primary skin irritation and dermal sensitization)
Medical Glove Guidance Manual - Labeling
FDA 21 CFR 880.6250 (Patient Examination Gloves regulations)

8. The Sample Size for the Training Set:

Not applicable. Examination gloves are physical devices, not machine learning models. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

Summary

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DEC 13 2013

510(k) SUMMARY

1.0 Submitter:

Name:	Mr. Kirk Penner
Address:	WRP Asia Pacific Sdn BhdLot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi,43900 Sepang, Selangor Darul Ehsan, MALAYSIA
Phone No.:	+60 3 8706 1486
Fax No.:	+60 3 8706 1485

Date of Summary Prepared: 25 July 2013

2.0 Name of the device:

Dermagrip Powder Free Black Nitrile Patient Examination Gloves, Non-Sterile Common Name: Exam Gloves Classification Name: Patient Examination Gloves (21 CFR 880.6250 product code LZA)

3.0 Identification of The Legally Marketed Devices that equivalency is claimed:

Dermagrip-N Powder Free Blue Nitrile Examination Gloves 510(k) : K022904 MDL : D036500 Regulatory Class I Product Code : LZA

4.0 Description of The Device:

Powder Free Black Nitrile Patient Examination Glove, Non-Sterile meet all the requirements of ASTM standard D6319-10 and FDA 21 CFR 880.6250.

The powder free nitrile examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.

5.0 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 or finger to prevent contamination between patient and examiner.

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510(k) SUMMARY

6.0 Summary of the Technological Characteristics of the Device:

The Powder Free Black Nitrile Examination Gloves, Non-Sterile are summarized with the following technological characteristics compared to ASTM D6319 or equivalent standards.

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
		Predicate	Current
Name	-	Dermagrip-NPowder FreeBlue NitrileExaminationGloves	DermagripPowder FreeBlack NitrilePatientExaminationGloves, Non-Sterile
Sterility status	ISO11137-1:2006	Non-Sterile	Non-Sterile
Dimensions	ASTM D6319-10	Meets	Meets
Physical Properties	ASTM D6319-10	Meets	Meets
Thickness	ASTM D6319-10	Meets	Meets
Powder Free	ASTM D6124-06	Meets< 2 mg/glove	Meets< 2 mg/glove
Biocompatibility	Primary SkinIrritation -ISO 10993-10:2002(E) &Consumer ProductSafety Commission,Tittle 16, Chapter II,Part 1500	Passes(Not a primaryskin irritant)The PrimaryIrritation Indexwas "0.125".	Passes(Non PrimaryIrritant)There was noerythema oroedema notedon abraded ornon-abradedsites at 24±1hours and 72±1hours afterapplication. ThePrimaryIrritation Index(PII) of testmaterial was"0".
CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
		Predicate	Current
Dermal Sensitization	ISO 10993-10:2002(E) &Consumer ProductSafety Commission,Tittle 16, Chapter II,Part 1500.3(c)(4)	Passes(Not a contactsensitizer)There was nopositive allergicreactionobserved duringthe challengephase (at 24hours and 48hours) amongthe testedmaterial andthe negativecontrol.	Passes(Not a contactsensitizer)There was nopositive allergicreactionobserved duringthe challengephase (at 0±2,24±2 hours and48±2 hours) inanimals treatedwith the testmaterial andnegativecontrol.
Watertight (1000ml)	ASTM D5151-06	Passes	Passes
Intended use	-	The powder freeblue Nitrileexaminationglove, non-sterile is adisposabledevice and ismade ofsynthetic rubberintended formedicalpurposes that isworn on theexaminer'shand or fingerto preventcontaminationbetween patientand examiner.	A patientexaminationglove is adisposabledevice intendedfor medicalpurposes that isworn on theexaminer'shand or fingerto preventcontaminationbetween patientand examiner.
Material	ASTM D6319-10	Nitrile	Nitrile
Color	-	Blue	Black
Texture	-	Finger textured	Finger textured
Size	Medical GloveGuidance Manual -Labeling	SmallMediumLargeExtra Large	Extra SmallSmallMediumLargeExtra Large
Single Use	Medical GloveGuidance Manual -Labeling	Single use	Single use
Manufacturer(s)	-	WRP Asia PacificSdn Bhd	WRP Asia PacificSdn Bhd

WRP Summary, Section D, K132484, Page 2 of 4

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510(k) SUMMARY

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510(k) SUMMARY

There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods except for color and thickness. The current device is black in color and thinner than the predicate device, however it meets the ASTM standards.

7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned immediately above (ASTM Requirements).

8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data

Not applicable - Clinical data is not needed for gloves or for most devices cleared by the 510(k) process.

9.0 Conclusion

Dermagrip Powder Free Black Nitrile Patient Examination Glove, Non-Sterile will perform according to the gloves performance standards referenced in section 6.0 above and meet ASTM standards, and FDA requirements for water leak test on pinhole AQL. Consequently, the device is safe, effective and substantially equivalent to currently marketed devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is positioned around the upper half of the circle.

Public Health Service

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

December 13, 2013

Mr. Kirk Penner Head of Department Product Management & Regulatory Affairs WRP Asia Pacific Sdn. Bhd. Lot 1, Jalan 3, Kawasan Perusahaan Bandar Baru Salak Tinggi 43900 Sepang Selangor Darul Ehsan MALAYSIA 43900

Re: K132484

Trade/Device Name: Dermagrip Powder Free Black Nitrile Patient Examination Gloves Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: October 28, 2013 Received: November 1, 2013

Dear Mr. Penner:

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. 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

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Page 2 - Mr. Penner

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours.

Image /page/5/Picture/8 description: The image shows a logo with the text "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID". The logo is black and white and has a stylized design. The text is arranged in a triangular shape, with the name at the top and the title below. The word "DAGRID" is at the bottom of the triangle. The word "FOR" is at the bottom right of the image.

Erin I. Keith, M.S. 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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3-4-4-4-6-11-6-14-1

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K 132484

Device Name

Dermagrip Powder Free Black Nitrile Patient Examination Gloves Non-Sterile

Indications for Use (Describe)

A patient contention 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.

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

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 601 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A

REMOVE THE INSTRUCTIONS ABOVE THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.1751 1883 1 FOR FDA USE ONLY. BE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) -05'00

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

Page for f

FORM FDA 3881 (9/13)

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.