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

It is the powder-free variation of the class I latex patient examination gloves made by on-line polymercoating and mild on-line chlorination process. The process modifies the surface characteristics and causes it to remain tack-free without the use of any dusting or donning powder.

AI/ML Overview

The document is a 510(k) Premarket Notification for "Latex Examination Gloves Powder Free". It does not describe an AI/ML medical device, therefore, the requested information for acceptance criteria and study details for such a device is not applicable.

The document focuses on demonstrating substantial equivalence to a predicate device (K152593) for patient examination gloves.

However, I can extract the acceptance criteria and performance of the device based on the non-clinical tests mentioned, as they serve a similar purpose of demonstrating safety and effectiveness for this medical device.

1. Table of acceptance criteria and the reported device performance

Parameter	Acceptance Criteria (ASTM Specifications)	Reported Device Performance (K161833)	Status
Dimension (Length)
Size XSmall	220 mm min.	224mm-236mm	Meet Specification
Size Small	220 mm min.	225mm-240mm	Meet Specification
Size Medium	230 mm min.	235mm-246mm	Meet Specification
Size Large	230 mm min.	235mm-245mm	Meet Specification
Size XLarge	N/A	N/A	N/A
Thickness
Palm	0.08 mm min.	0.12mm-0.14mm	Meet Specification
Finger	0.08 mm min.	0.15mm-0.17mm	Meet Specification
Width
Size XSmall	70 ± 10 mm	73mm-75mm	Meet Specification
Size Small	80 ± 10 mm	82mm-87mm	Meet Specification
Size Medium	95 ± 10 mm	94mm-97mm	Meet Specification
Size Large	111 ± 10 mm	102mm-107mm	Meet Specification
Size XLarge	N/A	N/A	N/A
Physical Properties
Tensile Strength, Before Aging	18 MPa min.	21.18MPa-26.17MPa	Meet Specification
Stress at 500% Elongation	5.5 MPa max.	3.0MPa-4.2MPa	Meet Specification
Ultimate Elongation, Before Aging	650% min.	750.20%-820.20%	Meet Specification
Tensile Strength, After Aging	14 MPa min.	18.28MPa-23.88MPa	Meet Specification
Ultimate Elongation, After Aging	500% min.	550.40%-700.50%	Meet Specification
Water Leak Test, 1000 ml (AQL)
Before Aging	2.5	1.5 and below	Meet Specification
After Aging	2.5	2.5 and below	Meet Specification
Extractable Protein
Water Extractable Protein	50 µg/dm²	50 µg/dm² and below	Meet Specification
Residual Powder Content
Residual Powder Content	2 mg/glove max.	2 mg/glove and below	Meet Specification

2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes for each specific test (e.g., how many gloves were tested for length, thickness, or tensile strength). However, the tests were performed "as per ASTM D3578-05, Standard Specification for Rubber Examination Gloves and 21 CFR 800.20." These standards typically define the sampling plans. The data provenance is Malaysia, as the applicant, Careglove Global SDN BHD, is located in Seremban, Negeri Sembilan, Malaysia. The tests are non-clinical and would be considered prospective in the sense that they were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device that requires expert ground truth for image or data interpretation. The ground truth for the glove's performance is established by objective measurements against established industry standards (ASTM D3578-05).

4. Adjudication method for the test set
Not applicable, as it's not an AI/ML device requiring human adjudication of performance. The performance is determined by direct physical and chemical measurements.

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 an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The type of ground truth used
The ground truth is based on established industry standards and regulatory requirements, specifically:

ASTM D3578-05 (Standard Specification for Rubber Examination Gloves)
21 CFR 800.20 (dealing with devices that prevent contamination)
ISO 10993-10 (Biological evaluation of medical devices - Tests for irritation and skin sensitization)

These standards define the acceptable performance limits for the characteristics tested.

8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device, so there is no "training set" or ground truth for it. The ground truth for the device's performance is established by the aforementioned ASTM and ISO standards for physical characteristics and biocompatibility.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

May 26, 2017

Careglove Global SDN BHD Lim Kwee Shyan Managing Director Lot 17479, Lrg Senawang 3/2 Off Jln Senawang 3 Senawang In Seremban, Negeri Sembilan, 70450 MY

Re: K161833

Trade/Device Name: Latex Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: April 25, 2017 Received: April 28, 2017

Dear Lim Kwee Shyan:

This letter corrects our substantially equivalent letter of May 23, 2017.

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. Iisting 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.

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

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

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 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" (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 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,

Lori A. Wiggins -S6

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K161833
Device Name	LATEX EXAMINATION GLOVES POWDER FREE
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)
------------------------------------------------	-----------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)	Page 1 of 1	PSC Publishing Services (301) 443-6740 EF
----------------------	-------------	-------------------------------------------

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows a logo for a company called "CARE GLOVE." The word "CARE" is written in large, bold, blue letters on top. Below it, the word "GLOVE" is written in a lighter green color. There is a blue circle with a light green handprint inside it, placed in the middle of the word "GLOVE." Underneath the words "CARE GLOVE," the text "CAREPLUS-DESCARPACK" is written in smaller, dark blue letters.

REGLOVE GLOBAL

Senawang 3/2. Off Jalan Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Ma Fax: 60-6-6785377

K161833 510(K) SUMMARY

CAREGLOVE GLOBAL SDN BHD Applicant:

Lot 17479, Lorong Senawang 2/3 Location Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
Phone No. (60) 6 6782377 Fax No. (60) 6 6785377

Contact Person: Lim Kwee Shyan

Summary Preparation Date: 17th May, 2017

Device Information

LATEX EXAMINATION GLOVES POWDER FREE Trade Name:

Common Name: LATEX EXAMINATION GLOVES POWDER FREE

Classification Name: Patient Examination Gloves
Product Code: Latex – LYY

Regulation Number: 21 CFR 880.6250.

Device Description

Intended Use of 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.

Brief Description of Non-Clinical Test

Testing performed as per ASTM D3578-05, Standard Specification for Rubber Examination Gloves and 21 CFR 800.20. The subject device meet all the ASTM D3578-05 requirements. Primary skin irritation testing in the rabbit and Closed patch sensitization testing in the guinea pig were conducted in accordance with ISO 10993-10 indicate no irritation or sensitization.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows a logo for a company called "Care Glove". The word "CARE" is in large, bold, blue letters on top. Below it, the word "GLOVE" is in a lighter green color, with a light green handprint inside the "O". Underneath that, the words "CAREPLUS-DESCARPACK" are in smaller, red letters.

CAREGLOVE GLOBAL SDI Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com

Non-clinical laboratory and animal based test indicate that the powder free latex examination glove meets all the performance and biocompatibility requirements.

Summary of Technological Characteristic

Table 1; Comparison of Proposed and Predicate Device

Parameter	ASTMSpecifications	StandardReferences	Subject Device MeasuredValues, K161833		PredicateDevice,K152593
			Value	Status
Dimension
Length(size:XSmall), mm	220 min.	ASTM D 3578-05	224mm-236mm	MeetSpecification	MeetSpecification
Length(size:Small), mm	220 min	ASTM D 3578-05	225mm –240mm	MeetSpecification	MeetSpecification
Length (size:Medium), mm	230 min	ASTM D 3578-05	235mm –246mm	MeetSpecification	MeetSpecification
Length (size:Large), mm	230 min	ASTM D 3578-05	235mm –245mm	MeetSpecification	MeetSpecification
Length(size:XLarge), mm	N/A	ASTM D 3578-05	N/A	N/A	N/A
Thickness (palm),mm	0.08min.	ASTM D 3578-05	0.12mm-0.14mm	MeetSpecification	MeetSpecification
Thickness (finger),mm	0.08 min.	ASTM D 3578-05	0.15mm-0.17mm	MeetSpecification	MeetSpecification
Width (size:XSmall)	70 ± 10	ASTM D3578-05	73mm - 75mm	MeetSpecification	MeetSpecification
Width (size: Small),mm	80 ± 10	ASTM D3578-05	82mm-87mm	MeetSpecification	MeetSpecification
Width (size:Medium), mm	95 ± 10	ASTM D3578-05	94mm- 97mm	MeetSpecification	MeetSpecification
Width (size: Large),mm	111 ± 10	ASTM D3578-05	102mm-107mm	MeetSpecification	MeetSpecification
Width (Size:XLarge)	N/A	ASTM D3578-05	N/A	N/A	N/A

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image is a logo for a company called "Care Glove". The word "CARE" is written in large, bold, blue letters on top of the word "GLOVE", which is written in a lighter green color. In the middle of the word "GLOVE" is a blue circle with a light green hand in the center. Underneath the words "CARE GLOVE" is the text "CAREPLUS-DESCARPACK" in smaller, blue letters.

CAREGLOVE GLOBAL S

Lot 17479, Lorong Senawang 3/2, Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. Tel: 60-6-6782377, 60-6-6788377 Fax: 60-6-6785377 Email: info@careglove.com

Parameter	ASTMSpecifications	StandardReferences	Subject Device Measured		Predicate
			Values		Device
			K161833		K152593
			Value	Status
Physical Properties
Tensile Strength,Before Aging, MPa	18 min.	ASTM D 3578-05	21.18MPa-26.17MPa	MeetSpecification	MeetSpecification
Stress at 500%Elongation	5.5 MPa max.	ASTM D 3578-05	3.0MPa-4.2MPa	MeetSpecification	MeetSpecification
Ultimate Elongation,Before Aging, %	650 min.	ASTM D 3578-05	750.20%-820.20%	MeetSpecification	MeetSpecification
Tensile Strength,After Aging, Mpa	14 min.	ASTM D 3578-05	18.28MPa-23.88MPa	MeetSpecification	MeetSpecification
Ultimate Elongation,After Aging, %	500 min.	ASTM D 3578-05	550.40%-700.50%	MeetSpecification	MeetSpecification
Water Leak Test, 1000 ml
Before Aging, AQL	2.5	ASTM D 3578-05	1.5 and below	MeetSpecification	1.5 and below
After Aging, AQL	2.5	ASTM D 3578-05	2.5 and below	MeetSpecification	2.5 and below
Extractable Protein
Water ExtractableProtein, µg/dm²	50 µg/dm²	ASTM D 5712-10	50 µg/dm² andbelow	MeetSpecification	50 µg/dm² andbelow
Residual Powder Content
Residual PowderContent, mg/glove	2 mg/glovemax.	ASTM D 3578-05	2 mg/glove andbelow	MeetSpecification	2 mg/gloveand below

Summary of Clinical Testing

Not applicable.

Conclusions.

The conclusions drawn from nonclinical tests demonstrate that the subject device is a safe, as effective, and performs as well as or better than the legally marketed predicate device, K152593.

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.