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

The Dermagrip powder free blue nitrile patient 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 qloves 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

This document is a 510(k) summary for the Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile. It provides information about the device's characteristics and how it meets acceptance criteria, primarily through comparison to established standards and a predicate device.

Here's a breakdown of the requested information based on the provided text:

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

CHARACTERISTICS	STANDARDS	Acceptance Criteria (from Standards)	Reported Device Performance (Current)
Dimensions	ASTM D6319-10	Meets ASTM D6319-10 requirements	Meets
Physical Properties	ASTM D6319-10	Meets ASTM D6319-10 requirements	Meets
Thickness	ASTM D6319-10	Meets ASTM D6319-10 requirements	Meets (Note: Current device is thinner than predicate but still meets standard)
Powder Free	ASTM D6124-06	≤ 2 mg/glove	Meets (≤ 2 mg/glove)
Biocompatibility (Primary Skin Irritation)	ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500	Passes (Not a primary skin irritant)	Passes (Not a primary skin irritant). There was no erythema or oedema noted on test sites after (24±2), (48±2) and (72±2) hours. The Primary Irritation Index (PII) was "0".
Biocompatibility (Dermal Sensitization)	ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c)(4)	Passes (Not a contact sensitizer)	Passes (Not a contact sensitizer). There was no positive allergic reaction observed during the challenge phase at (0±2), (24±2) and (48±2) hours in animals treated with the test material and negative control.
Watertight (1000ml)	ASTM D5151-06	Passes (as per standard)	Passes
Intended use	N/A (Descriptive)	Disposable device for medical purposes to prevent contamination between patient and examiner.	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.
Material	ASTM D6319-10	Nitrile	Nitrile
Color	N/A (Descriptive)	Blue	Blue
Texture	N/A (Descriptive)	Finger textured	Finger textured
Size	Medical Glove Guidance Manual - Labeling	Small, Medium, Large, Extra Large (for predicate)	Extra Small, Small, Medium, Large, Extra Large
Single Use	Medical Glove Guidance Manual - Labeling	Single use	Single use

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

The document does not explicitly state the sample sizes used for each specific test (e.g., for biocompatibility, watertightness, etc.). It only indicates that the device's performance "Meets" the respective standards. The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective, beyond acknowledging that the manufacturer (WRP Asia Pacific Sdn Bhd) is located in Malaysia.

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)

This type of information is not applicable to the device described. The device is a patient examination glove, and its performance is assessed against established engineering and biocompatibility standards (ASTM, ISO), not through expert interpretation of medical images or clinical outcomes that require "ground truth" established by medical experts in a diagnostic context. The "ground truth" here is the pass/fail criteria defined by the standards.

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

Not applicable. As explained above, the assessment is against predefined technical and biological standards, not through adjudication of expert opinions on a test set.

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 device is a medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and effects on human readers are irrelevant.

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

Not applicable. This device is a physical product (a glove), not an algorithm or software.

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

The "ground truth" for this device's performance is based on established industry standards and regulatory requirements. For example:

Dimensions, Physical Properties, Thickness: Defined by ASTM D6319-10.
Powder Free: Defined by ASTM D6124-06 (≤ 2 mg/glove).
Biocompatibility: Defined by ISO 10993-10:2010(E) and Consumer Product Safety Commission regulations (absence of primary skin irritation, absence of dermal sensitization).
Watertight: Defined by ASTM D5151-06 (passing the water leak test).
Intended Use, Material, Color, Texture, Size, Single Use: Compliance with descriptive criteria or labeling guidance.

These standards provide objective, measurable criteria for the device's performance.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its development and testing follow established engineering and manufacturing quality control processes.

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

Not applicable, as no training set is used for this type of device.

Summary

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

August 7, 2014

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

Re: K133168

Trade/Device Name: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: July 1, 2014 Received: July 3, 2014

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 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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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 devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133168

Device Name

Dermagrip Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile

Indications for Use (Describe)

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.

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

] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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: 30 June 2014

2.0 Name of the device:

Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile Common Name: Exam Gloves Regulatory Class I 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:

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

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 finqer to prevent contamination between patient and examiner.

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510(k) SUMMARY

Summary of the Technological Characteristics of the Device: 6.0

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

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
		Predicate	Current
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 10993-10:2010(E) &Consumer ProductSafety Commission,Title 16, Chapter II,Part 1500	Passes(Not a primaryskin irritant)The PrimaryIrritation Indexwas "0.125".	Passes(Not a primaryskin irritant)There was noerythema oroedema notedon test sitesafter (24±2),(48±2) and(72±2) hours.The PrimaryIrritation Index(PII) was "0".
	Dermal SensitizationISO 10993-10:2010(E) &Consumer ProductSafety Commission,Title 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) and(48±2) hours inanimals treatedwith the testmaterial andnegativecontrol.

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510(k) SUMMARY

CHARACTERISTICS	STANDARDS	DEVICE PERFORMANCE
		Predicate	Current
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	Blue
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

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

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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 Blue Nitrile Patient Examination Gloves, 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 substantially equivalent to the predicate device.

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.