PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL

• K Number: K091471
• Device Name: PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL
• Manufacturer: CARTAGLOVES S.A.
• Date Cleared: 2009-10-15 ( 150 days)
• Product Code: LYZ
• Regulation Number: 880.6250

Intended Use

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

Predicate Devices

K983494

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a standard examination glove and the summary contains no mention of AI/ML or related concepts.

Therapeutic

No.
A therapeutic device is used to treat a disease or condition, while this device, a patient examination glove, is primarily used to prevent contamination, which is a protective rather than a therapeutic function.

Diagnostic

No
The device is described as an examination glove, intended to prevent contamination between patient and examiner. This function is protective, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "Powder-Free Vinyl Examination Glove," which is a physical hardware product, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the glove is "worn on the examiner's hand to prevent contamination between patient and examiner against potentially infectious materials." This is a barrier function, not a diagnostic function performed in vitro (outside the body).
• Device Description: It's described as a "Powder-Free Vinyl Examination Glove," which is a physical barrier device.
• Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
  • Analyzing samples (blood, urine, tissue, etc.)
  • Detecting specific substances or markers
  • Providing diagnostic information about a patient's condition
  • Using reagents or assays

The purpose of this device is to protect the user and the patient from the transmission of infectious agents through direct contact, which is a function of a general medical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LYZ

Device Description

Powder-Free Vinyl Examination Glove

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Hand

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Examiner (medical professional)

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The performance test data that support a determination of substantial equivalence are described in Section 7 of the submission. The device meets ASTM D 5250-06 and D 6124-06 standards for dimensions, physical properties (tensile strength, ultimate elongation), freedom from pinholes (AQL 2.5, Level I), and powder-free requirements. Biocompatibility testing (Cytotoxicity - Agar Diffusion, Primary Skin Irritation, Repeated Patch Dermal Sensitization) passed based on ISO 10993.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K983494

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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K091471

OCT 1 5 2009

Cartagloves S.A.

Zona Franca La Candelaria, Mamonal, Cartagena, Colombia Telephone: [phone] Fax: [phone]

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: [phone] Fax: [phone]

Contact:

Sam Kao Telephone No. [phone] FAX No. [phone] 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: [phone] - Fax: [phone]

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 [phone] or [phone] 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"

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.

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

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510(k) Number: