A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.

Device Description

Powder-Free Vinyl Examination Glove

AI/ML Overview

The provided documentation describes the acceptance criteria and a study demonstrating that the Cartagloves S.A. Powder-Free Vinyl Examination Glove meets these criteria, supporting its substantial equivalence claim.

1. Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Standard)	Reported Device Performance (Applicant Device Specification)
Dimensions	Meets ASTM D 5250-06
Width (Small)	85 mm	85 +/- 5 mm
Width (Medium)	95 mm	95 +/- 5 mm
Width (Large)	105 mm	105 +/- 5 mm
Width (X-Large)	115 mm	115 +/- 5 mm
Length (all sizes)	230 mm minimum	250 +/- 10 mm
Thickness (Finger)	0.05 mm minimum	0.05 mm minimum
Thickness (Palm)	0.08 mm minimum	0.1 mm minimum
Physical Properties	Meets ASTM D 5250-06
Tensile Strength (Before Aging)	9 MPa minimum	9 MPa minimum
Tensile Strength (After Aging)	9 MPa minimum	9 MPa minimum
Ultimate Elongation (Before Aging)	300% minimum	300% minimum
Ultimate Elongation (After Aging)	300% minimum	300% minimum
Freedom from Pinholes	Meets ASTM D 5250-06 and ASTM D 5151-99	AQL 2.5, Level I (Water Leak Test)
Powder Free	Meets ASTM D 6124-06 and ASTM D 5250-06	Adheres to standard requirements
Biocompatibility	Based on ISO 10993
Cytotoxicity - Agar Diffusion	N/A (Standard for "Passed")	Passed
Primary Skin Irritation	N/A (Standard for "Passed")	Passed
Repeated Patch Dermal Sensitization	N/A (Standard for "Passed")	Passed

2. Sample size used for the test set and the data provenance

The documentation does not explicitly state the specific "sample size" for each test (e.g., number of gloves tested for dimensions, physical properties, or pinholes). However, it implies that the testing was conducted according to the sampling plans outlined within ASTM D5250, ASTM D5151, and ASTM D6124, which typically include specific AQL (Acceptable Quality Level) and inspection levels for quality control.

The data provenance is not explicitly stated in terms of country of origin but is from the applicant, Cartagloves S.A., located in Cartagena, Colombia. The testing appears to be internal to the manufacturer or conducted by a designated lab on their behalf. The data is presented as retrospective performance data collected to support the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this device. The device is a patient examination glove, and its performance is evaluated against established physical, chemical, and biocompatibility standards (ASTM and ISO), not subjective expert interpretation of images or clinical data. There is no concept of "ground truth" established by experts in the context of these types of engineering and material performance tests.

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

This question is not applicable to this device. Adjudication methods like 2+1 or 3+1 are used in studies where subjective interpretation (e.g., medical image reading) requires consensus among multiple evaluators. For the performance testing of examination gloves, the measurements are objective (e.g., tensile strength, dimensions, pinhole count) and determined by standardized test procedures, not expert adjudication.

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 question is not applicable to this device. An MRMC study with AI assistance is relevant for diagnostic devices that analyze medical images or data. The Cartagloves S.A. device is an examination glove, which is a physical barrier device, and does not involve human readers or AI in its intended use or performance evaluation.

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

This question is not applicable to this device. "Standalone performance" typically refers to the performance of an AI algorithm or an automated diagnostic system operating without human interaction. This is not relevant for a physical medical device like an examination glove.

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

The "ground truth" for the performance of the examination glove is defined by adherence to published and accepted industry standards:

ASTM D 5250-06 ("Standard Specification for Poly(vinyl chloride) Gloves for Medical Application")
ASTM D 5151-99 (Standard Test Method for Detection of Holes in Medical Gloves)
ASTM D 6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
ISO 10993 (Biological evaluation of medical devices)

The device's performance against these quantifiable criteria (e.g., specific dimensions, tensile strength values, AQL levels for pinholes) constitutes the "ground truth" for its safety and effectiveness relative to the specified standards.

8. The sample size for the training set

This question is not applicable to this device. "Training set" refers to data used to train machine learning algorithms. The Cartagloves S.A. device is an examination glove, and its manufacturing and testing do not involve machine learning or AI.

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

This question is not applicable to this device, as there is no "training set" in the context of examination glove manufacturing and testing.

Summary

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K091471

OCT 1 5 2009

Cartagloves S.A.

Zona Franca La Candelaria, Mamonal, Cartagena, Colombia Telephone: +57-1-213-9702 Fax: +57-1-213-9709

Premarket Notification 510(k)

Powder-Free Vinyl Examination Glove

21.0 Summary

510(k) Summary of Safety and Effectiveness Information [1]
Submitter: Cartagloves S.A. [2] Mamonal, Zona Franca La Candelaria, Cartagena. Colombia Telephone: +57-1-213-9702 Fax: +57-1-213-9709

Contact:

Sam Kao Telephone No. +1-(714) 953-5326 FAX No. +1-(714) 953-5550 E-mail: sam(a)kalmedsupply.com

May 11, 2009 Date:

Trade name: (Multiple private labels) [3] Powder-Free Examination Glove, Vinyl Synthetic Common name: Classification name: Patient examination gloves, powder-free (per proposed 21 CFR §880.6250)
[4] The predicate device, Glormed International's powder-free vinyl exam glove, listed on 510(k) K983494, is a Class I, powder-free vinyl exam glove 80LYZ that meets all of the requirements of ASTM D 5250-06, "Standard Specification for Poly(vinyl chloride) Gloves for Medical Application."
The powder-free vinyl exam glove meets the current specifications of ASTM D ારો 5250-06, "Standard Specification for Poly(vinyl chloride) Gloves for Medical Application. "
A patient examination glove is a medical device intended for medical purposes that િ is worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials.
Applicant's device comparison with FDA required technological characteristics: [7]

Characteristics	Standard
Dimensions	Meets ASTM D 5250-06
Physical Properties	Meets ASTM D 5250-06
Freedom from pinholes	Meets ASTM D 5250-06 and ASTM D 5151-99
Powder Free	Meets ASTM D 6124-06 and ASTM D 5250-06

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K091471

Cartagloves S.A.

Zona Franca La Candelaria, Mamonal, Cartagena, Colombia Telephone: +57-1-213-9702 - Fax: +57-1-213-9709

Premarket Notification 510(k)

Powder-Free Vinyl Examination Glove

Biocompatibilty: (based on ISO 10993)
Cytotoxicity - Agar Diffusion	Passed
Primary Skin Irritation	Passed
Repeated Patch Dermal Sensitization	Passed

Measured Parameter of Applicant Device Compared to Standard:

ASTM D5250 / ASTM D 6124 Requirement		Applicant Device Specification
Width (mm)
Small	85	85 +/- 5
Medium	95	95 +/- 5
Large	105	105 +/- 5
X-Large	115	115 +/- 5
Length (mm) - all sizes	230 minimum	250 +/- 10
Thickness (mm) - all sizes
Finger	0.05 minimum	0.05 minimum
Palm	0.08 minimum	0.1 minimum
Physical Testing
Tensile Strength		Before Aging	After Aging
(in MPa)	9 minimum	9 min	9 min
Ultimate Elongation
(in %)	300% minimum	300% min	300% min
Water Leak Test	AQL 2.5, Level I	AQL 2.5, Level I

Both its intended use and physical characteristics is equivalent to legally marketed vinyl powder-free examination gloves. It is substantially equivalent to gloves approved as Glormed International's vinyl powder-free glove K983494.

The performance test data that support a determination of substantial equivalence [8] are described above in Section 7.
Clinical data are not needed for examination gloves. જિ
[10] (Multiple private labels) Powder-Free Vinyl Examination Glove is safe and effective and will perform according to glove performance standards referenced in Section 7 above, thereby meeting ASTM D5250 and D6124 standards, FDA requirements, pinhole AQL requirement, and labeling claims for the product. Consequently, this patient examination glove is substantially equivalent to currently marketed patient examination gloves.
[11] This summary will include any additional safety and effectiveness information reasonably deemed necessary by FDA.

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Image /page/2/Picture/0 description: The image shows a circular seal with an eagle in the center. The eagle is facing right and has its wings spread. The text around the seal reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-0609 Silver Spring, MD 20993-0002

Cartagloves S. A. C/O Mr. Sam Kao Project Manager KalMed Supply, Incorporated 2700 North Main Street, Suite 820 Santa Ana, California 92705

OCT 1 5 2009

Re: K091471

Trade/Device Name: Vinyl Patient Examination Glove, Powder-Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: September 9, 2009 Received: September 15, 2009

Dear Mr. Kao:

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.

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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Page 2- Mr. Kao

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 (OS) 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,

Anthony D. Watson Jr.

Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification 510(k)

Powder-Free Vinyl Examination Glove

3.0 Indications for Use Statement:

Indications for Use

510(k) Number (if known): K 09 | 4 7 |

Device Name: Vinyl Patient Examination Glove, Powder-Free

Indications For Use:

Based upon 21 CFR §880.6250 "Patient examination glove, powder-free"

Over-The-Counter Use _ Prescription Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Shule A Murphy MD
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of

510(k) Number:

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.