A sterile latex surgical glove, powder free is a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.

Device Description

The subject device is a powder-free variation of the class I latex surgical gloves made by on-line polymercoating process. This 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 provided document is a 510(k) summary for a medical device: "Sterile Latex Surgical Gloves, Powder Free." It details the device's characteristics, comparison to a predicate device, and the results of non-clinical testing. It explicitly states that clinical testing was "Not applicable." Therefore, the document does not contain information about a study proving the device meets acceptance criteria related to a diagnostic or AI-based medical device performance study.

The questions in the prompt relate to the evaluation of an AI or diagnostic device, asking about sample sizes, expert ground truth, MRMC studies, and training sets. This information is not relevant to a 510(k) submission for surgical gloves, which are assessed based on physical properties, sterility, and biocompatibility.

However, I can extract the acceptance criteria and reported device performance for the surgical gloves based on the provided tables.

Here's the information derived from the document, tailored to the context of surgical gloves:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting the specifications of ASTM D3577-15 and other relevant standards (ISO 11737-2, ISO 10993-10, ISO 10993-5, ISO 10993-11, USP General Chapter 40). The reported device performance indicates whether the subject device "Meets" or "Passes" these specifications.

Characteristic	Standard	Specification	Reported Device Performance (Subject Device K190241)
Dimension (Length)	ASTM D3577-15
Length (size: 5.5), mm		245 min	Meet 245mm min
Length (size: 6.0), mm		265 min	Meet 265mm min
Length (size: 6.5), mm		265 min	Meet 265mm min
Length (size: 7.0), mm		265 min	Meet 265mm min
Length (size: 7.5), mm		265 min	Meet 265mm min
Length (size: 8.0), mm		265 min	Meet 265mm min
Length (size: 8.5), mm		265 min	Meet 265mm min
Length (size: 9.0), mm		265 min	Meet 265mm min
Dimension (Thickness)	ASTM D3577-15
Thickness (cuff), mm		0.10 min	Meet 0.10mm min
Thickness (palm), mm		0.10 min	Meet 0.10mm min
Thickness (finger), mm		0.10 min	Meet 0.10mm min
Dimension (Width)	ASTM D3577-15
Width (size: 5.5), mm		70 ± 6	Meet 70 ± 6 mm
Width (size: 6.0), mm		76 ± 6	Meet 76 ± 6 mm
Width (size: 6.5), mm		83 ± 6	Meet 83 ± 6 mm
Width (size: 7.0), mm		89 ± 6	Meet 89 ± 6 mm
Width (size: 7.5), mm		95 ± 6	Meet 95 ± 6 mm
Width (size: 8.0), mm		102 ± 6	Meet 102 ± 6 mm
Width (size: 8.5), mm		108 ± 6	Meet 108 ± 6 mm
Width (size: 9.0), mm		114 ± 6	Meet 114 ± 6 mm
Water Leak Test	ASTM D3577-15, ASTM D5151-06
Before Aging, AQL		G-I, AQL 1.5 (FDA GII, AQL 1.5)	Meet AQL 1.5
After Aging, AQL			Meet AQL 1.5
Physical Properties (Before Aging)	ASTM D3577-15
Tensile Strength (MPa)		Min. 24	Meet 24MPa min.
Ultimate Elongation (%)		Min. 750	Meet 750% min
Stress at 500% Elongation (MPa)		Max. 5.5	Meet 5.5 MPa max
Physical Properties (After Aging)	ASTM D3577-15
Tensile Strength (MPa)		Min. 18	Meets 18MPa min
Ultimate Elongation (%)		Min. 560	Meet 560% min.
Residual Powder Content	ASTM D3577-15, ASTM D6124-06	Max. 2mg/glove	Meet 2mg/glove max.
Extractable Protein Content	ASTM D5712-10	50 µg/dm² and below	Meet Specification
Biocompatibility Tests
Primary Skin Irritation Test	ISO 10993-10	No Animal Irritation	Passes (did not cause an irritant response)
Skin Sensitization Test	ISO 10993-10	No Animal Sensitization	Passes (did not produce a skin sensitization effect)
Cytotoxicity Test	ISO 10995-5	Non-cytotoxicity	moderate-cytotoxicity at 6 cm²/mL extraction
Acute Toxicity Oral	ISO 10993-11	No toxic	No adverse biological reaction
Pyrogenic Test	USP General Chapter 40	Non pyrogenic	Non pyrogenic

Regarding the specific questions about an AI/diagnostic device evaluation:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not applicable. The device is a surgical glove, not a diagnostic or AI device. The testing involved physical and chemical properties and biocompatibility, not patient data.

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 information is not applicable. Ground truth as understood in AI/diagnostic studies (e.g., disease presence) is not relevant for surgical gloves. The "ground truth" for the gloves are the established international standards for their physical, chemical, and biological properties.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are used in interpreting ambiguous diagnostic findings, which is not relevant for surgical gloves.

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:
This information is not applicable. MRMC studies are used to evaluate human reader performance with and without AI assistance in diagnostic tasks. This device is a surgical glove.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. Standalone algorithm performance is relevant for AI devices. This device is a physical product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For surgical gloves, the "ground truth" is defined by adherence to recognized international standards (e.g., ASTM, ISO, USP) for physical properties, sterility, and biocompatibility. This involves laboratory testing using defined methodologies, not clinical outcomes data or expert diagnostic consensus.

8. The sample size for the training set:
This information is not applicable. Training sets are used for machine learning. This document describes testing of manufactured physical products, not an AI model.

9. How the ground truth for the training set was established:
This information is not applicable. There is no training set for a surgical glove.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 30, 2019

Careglove Global Sdn Bhd Lim Shyan Managing Director Lot 17479, Lrg Senawang 3/2, Off Jln Senawang 3, Senawang In Seremban, 70450 My

Re: K190241

Trade/Device Name: Sterile Latex Surgical Glove, Powder Free Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO Dated: November 8, 2019 Received: November 12, 2019

Dear Lim Shyan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K190241

Device Name

STERILE LATEX SURGICAL GLOVES, POWDER FREE

Indications for Use (Describe)

A sterile latex surgical glove, powder free is a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.

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)

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Image /page/3/Picture/0 description: The image shows the logo for Care Glove. The word "CARE" is in large, blue, sans-serif font. Below that, the word "GLOVE" is in a smaller, yellow, sans-serif font. In the middle of the word "GLOVE" is a blue circle with a yellow hand in the center. Below that, the words "CAREPLUS-DESCARPACK" are in a small, black, sans-serif font.

OVE GLO

orong Senawang 3/2, Off Jalan Senaw vang Industrial Estate, 70450 Seremban, Negeri Sembilan, Malaysia. 82377, 60-6-6788377 Fax: 60-6-6785377 @careelove.com

K190241

510(K) SUMMARY

CAREGLOVE GLOBAL SDN BHD Applicant:

Location Lot 17479, Lorong Senawang 2/3 Off Jalan Senawang 3, Senawang Industrial Estate, 70450 Seremban, Negeri Sembilan Darul Khusus, Malaysia.
Fax No. (60) 66785377 Phone No. (60) 6 6782377

Contact Person: Lim Kwee Shyan

Summary Preparation Date: 23rd December, 2019

Device Information

Trade Name:	STERILE LATEX SURGICAL GLOVES, POWDER FREE
Common Name:	STERILE LATEX SURGICAL GLOVES, POWDER FREE
Classification Name:	Surgeon's Gloves
Product Code:	KGO
Regulation:	21 CFR 878.4460
Device Class:	I

Predicate device

Device Name: STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)

Company name: SUPERMAX GLOVE MANUFACTURING SDN BHD

510(K) Number: K014230

Device Description

Indication for Use

A sterile latex surgical glove, powder free is a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.

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Image /page/4/Picture/0 description: The image shows the logo for "CARE GLOVE" in a stacked format. The word "CARE" is in a larger, blue font on top, while "GLOVE" is in a smaller, yellow font below it. A hand graphic is placed within the word "GLOVE". The text "CAREPLUS-DESCARPACK" is at the bottom in a smaller, sans-serif font.

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

Summary of the Technological Characteristics of the Device

Table 1: Comparison of the Technological Characteristics of the Subject and Predicate Device.

Characteristic	Standard	Specification	Subject DeviceSterile LatexSurgical PowderFreeK190241	Legally MarketedPredicate DeviceK014230	Remark
Product Code	-	-	KGO	KGO	Same
Indication for UseStatement	-	-	A sterile latexsurgical glove,powder free is adisposable deviceintended for medicalpurposes that is wornby operating roompersonnel to protecta surgical woundfrom contamination.	A sterile latex surgicalglove, powder free is adisposable deviceintended for medicalpurposes that is wornby operating roompersonnel to protect asurgical wound fromcontamination.	Same
Design	-	-	Powder Free, Sterile,Hand Specific,Beaded Cuff	Powder Free, Sterile,Hand Specific, BeadedCuff	Same
Construction	-	-	Hand Specific,Polymer Coated orChlorinated, LatexSurgical Gloves,Powder Free	Hand Specific, PolymerCoated or Chlorinated,Latex Surgical Gloves,Powder Free withProtein Claim (50Microgram or less PerGram of Gloves)	Similar
Color Information	-	-	Natural	Natural	Same
Material	-		Natural Rubber	Natural Rubber	Same
Single Use	-	-	Yes	Yes	Same
Sterility	ISO11737-2	-	Sterile	Sterile	Same
Sterilization Method	-	-	Gamma Irradiation	Gamma Irradiation	Same
Packaging	-	-	Packed in Pouches	Packed in Pouches	Same
Table 2: Summary of the Non-Clinical Testing for the Subject Device and Comparison to the Predicate Device.
Characteristic	Standard	Specification	Subject DeviceSterile LatexSurgical PowderFreeK190241	Legally MarketedPredicate DeviceK014230	Remark
Dimension	ASTMD3577-15
Length (size: 5.5), mm		245 min	Meet 245mm min	Meet 245mm min	Same
Length (size: 6.0), mm		265 min	Meet 265mm min	Meet 265mm min
Length (size: 6.5), mm		265 min	Meet 265mm min	Meet 265mm min
Length (size: 7.0), mm		265 min	Meet 265mm min	Meet 265mm min
Length (size: 7.5), mm		265 min	Meet 265mm min	Meet 265mm min
Length (size: 8.0), mm		265 min	Meet 265mm min	Meet 265mm min
Length (size: 8.5), mm		265 min	Meet 265mm min	Meet 265mm min
Length (size: 9.0), mm		265 min	Meet 265mm min	Meet 265mm min
Thickness (cuff), mm		0.10 min	Meet 0.10mm min	Meet 0.10mm min	Same
Thickness (palm), mm		0.10 min	Meet 0.10mm min	Meet 0.10mm min
Thickness (finger), mm		0.10 min	Meet 0.10mm min	Meet 0.10mm min
Width (size: 5.5), mm		$70 \pm 6$	Meet $70 \pm 6$ mm	Meet $70 \pm 6$ mm
Width (size: 6.0), mm		$76 \pm 6$	Meet $76 \pm 6$ mm	Meet $76 \pm 6$ mm
Width (size: 6.5), mm		$83 \pm 6$	Meet $83 \pm 6$ mm	Meet $83 \pm 6$ mm	Same
Width (size: 7.0), mm		$89 \pm 6$	Meet $89 \pm 6$ mm	Meet $89 \pm 6$ mm
Width (size: 7.5), mm		$95 \pm 6$	Meet $95 \pm 6$ mm	Meet $95 \pm 6$ mm
Width (size: 8.0), mm		$102 \pm 6$	Meet $102 \pm 6$ mm	Meet $102 \pm 6$ mm
Width (size: 8.5), mm		$108 \pm 6$	Meet $108 \pm 6$ mm	Meet $108 \pm 6$ mm
Width (size: 9.0), mm		$114 \pm 6$	Meet $114 \pm 6$ mm	Meet $114 \pm 6$ mm
Water Leak Test,1000 ml	ASTMD3577-15 ASTMD5151-06				Same
Before Aging, AQL		G- I, AQL 1.5(FDA GII, AQL1.5)	Meet AQL 1.5	Meet AQL 1.5
After Aging, AQL			Meet AQL 1.5	Meet AQL 1.5
Physical Properties	ASTMD3577-15
(Before Ageing)i) TensileStrength(MPa)		Min. 24	Meet 24MPa min.	Meet 24MPa min.	Similar
ii) Ultimate Elongation(%)		Min. 750	Meet 750% min	Meet 750% min
ii) Stress at 500%Elongation (MPa)		Max. 5.5	Meet 5.5 MPa max	Meet 5.5 MPa max
(After Aging)i) Tensile Strength(MPa)		Min. 18	Meets 18MPa min	Meets 18MPa min
ii) Ultimate Elongation(%)		Min. 560	Meet 560% min.	Meet 560% min.
Characteristic	Standard	Specification	Subject DeviceSterile LatexSurgical PowderFreeK190241	Legally MarketedPredicate DeviceK014230	Remark
ResidualPowderContent	ASTMD3577-15ASTMD6124-06	Max.2mg/glove	Meet 2mg/glove max.	Meet 2mg/glove max	Similar
ResidualPowderContent, mg/glove
ExtractableProteinContent	ASTMD5712-10	50 µg/dm²and below	Meet Specification	50 µg/dm² and below	Similar
Water ExtractableProtein Content,µg/dm²
Biocompatibility Test
i) Primary SkinIrritation Test	ISO 10993-10	No AnimalIrritation	Passesi) Primary SkinIrritation Test.Conclusion: Under theconditions of thisstudy the test materialdid not cause anirritant response	Passesi)Primary Skin IrritationTest.Conclusion: Under theconditions of this studythe test material did notcause anirritantresponse.	Same
ii) Skin SensitizationTest	ISO 10993-10	No AnimalSensitization	ii)DermalSensitizationTest.Conclusion: Underthe conditions of thisstudy, the testmaterial did notproduce a skinsensitization effect	ii) Dermal SensitizationTest.Conclusion: Under theconditions of this study,the test material did notproduce a skinsensitization effect	Same
iii) Cytotoxicity Test	ISO 10995-5	Non-cytotoxicity	moderate-cytotoxicityat 6 cm²/mLextraction	Data not available frommanufacture	Different
iv) Acute Toxicity Oral	ISO 10993-11	No toxic	No adverse biologicalreaction	Data not available frommanufacture	Different
v) Pyrogenic Test	USPGeneralChapter40,	Nonpyrogenic	Non pyrogenic	Data not available frommanufacture	Different

Summary of Non-Clinical Testing

Testing performed as per ASTM D3577-15, Standard Specification for Rubber Surgical Gloves, and 21 CFR 878.4460. The subject device meets all the ASTM D3577-15 requirements. The table below summarizes the non-clinical tests performed and the standards used in this submission.

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Image /page/5/Picture/0 description: The image shows the logo for Care Glove. The word "CARE" is in large blue letters on top of the word "GLOVE" which is in a light yellow color. In the middle of the word "GLOVE" is a blue circle with a light yellow hand in the center. Below the word "GLOVE" is the text "CAREPLUS-DESCARPACK".

CAREGLOVE GLOBAL SDN B

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Image /page/6/Picture/0 description: The image shows the logo for Care Glove. The word "CARE" is in large blue letters on top of the word "GLOVE" in smaller yellow letters. A hand is in the middle of the word "GLOVE". The words "CAREPLUS-DESCARPACK" are in small blue letters at the bottom.

CAREGLOVE GLOBAL SD

Non-clinical laboratory and animal-based tests indicate that the sterile latex surgical glove, powder free meets all the performance and biocompatibility requirements for the referenced standards.

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Image /page/7/Picture/0 description: The image shows a logo with the words "CARE GLOVE" stacked on top of each other. The word "CARE" is in blue, and the word "GLOVE" is in yellow, with a yellow hand in the middle of the word. Below the words "CARE GLOVE" is the text "CAREPLUS-DESCARPACK" in a smaller font size.

CAREGLOVE GLOBAL SD

Summary of Clinical Testing

Not applicable.

Conclusions: The conclusions drawn from nonclinical tests demonstrate that the subject device (K190241) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K014230.

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).