An Examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger, to prevent contamination between the patient and examiner.

Device Description

The device is a glove with five fingers made from natural rubber that covers the hand on both sides up to the wrist, using a dip technology manufacturing process. The gloves are ambidextrous and therefore can be donned on either hand. The gloves are non sterile and for single use only, to be discarded after each examination is complete. The glove acts as a barrier between the examiner and the subject being examined in order to prevent contamination between the examiner and the subject.

AI/ML Overview

This document describes the premarket notification (510(k)) for the "Preventive Care, Inc. Exam Perfect Powderfree Latex Examination Gloves Coated with Allogel®".

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard Requirement)	Reported Device Performance (POWDER FREE LATEX EXAM GLOVES COATED WITH ALLOGEL® RESULTS)
Watertight (1000ml) (ASTM D5151, ISO 2859 Version 10-2006 GI AQL2.5)	Pass G1 AQL 2.5
Length (mm)
Size XS: Min 220	240 mm minimum for all sizes
Size S: Min 220
Size M: Min 230
Size L: Min 230
Size XL: Min 230
Palm Width (mm)
Size XS: 70 ± 10	75 - 80
Size S: 80 ± 10	83 - 84
Size M: 95 ± 10	94 - 96
Size L: 110 ± 10	107 - 109
Size XL: 120 ± 10	113 - 114
Thickness (mm) (Single Layer)
Finger: Min 0.05	Min 0.12
Palm: Min 0.05	Min 0.10
Cuff: Min 0.05	Min 0.08
Physical Properties (ASTM D 412)
Before Aging:
Tensile Strength (MPa): Min 14	18 - 31
Ultimate Elongation (%): Min 500	530 - 600
After Aging:
Tensile Strength (MPa): Min 14	18 - 29
Ultimate Elongation (%): Min 400	500 - 550
Powder Content (ASTM D6124)
Max 2.0 mg/glove	Below 2.0 mg/glove
Residual Latex Proteins
Max 200 micro grams/dm2	Max 200 micro grams/dm2

Additional Acceptance Criteria and Reported Performance from Section 10 (Substantial Equivalence Comparison Table):

Acceptance Criteria (Predicate Requirement)	Reported Device Performance (Applicant Performance)
TENSILE STRENGTH BEFORE AGING MINIMUM: 14 MPA (Predicate)	18 MPA (Applicant)
AFTER AGING AT 70 DEG C 7 DAYS. MINIMUM: 14 MPA (Predicate)	17 MPA (Applicant)
ULTIMATE ELONGATION BEFORE AGING MIN.: 500% (Predicate)	797% (Applicant)
AFTER AGING AT 70 DEG C 7 DAYS. MINIMUM: 400% (Predicate)	753% (Applicant)
WIDTH AT PALM (MEDIUM) +/- 5 MM: 95 MM (Predicate)	98 MM (Applicant)
LENGTH (MEDIUM) +/- 5 MM: 245 MM (Predicate)	241 MM (Applicant)
THICKNESS AT PALM MINIMUM: 0.07 MM (Predicate)	0.11 MM (Applicant)
THICKNESS AT FINGER MINIMUM: 0.07 MM (Predicate)	0.13 MM (Applicant)
THICKNESS AT CUFF MINIMUM: 0.07 MM (Predicate)	0.08 MM (Applicant)
DETECTION OF PIN HOLES (ASTM D5151): AQL 2.5 MAX (Predicate)	AQL 1.5 (Applicant)
RESIDUAL POWDER: 2 MG/GLOVE (Predicate)	0.58 MG/GLOVE (MEDIUM) (Applicant)
MINIMUM SHELF LIFE: 3 YEARS (Predicate)	3 YEARS (Applicant)
POSITIVE BIOCOMPATABILITY TEST RESULTS: NON IRRITANT, NON SENSITIZER (Predicate)	NON IRRITANT, NON SENSITIZER (Applicant)

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

Sample Size: The document mentions "Data of an actual representative shipment is detailed in Section 14 (original submission)" for various tests. However, the specific sample sizes (e.g., number of gloves tested for watertight, tensile strength, etc.) are not explicitly stated in the provided text.
Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It refers to "an actual representative shipment," implying that the data was collected from manufactured products.

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

This device is an examination glove, and the "ground truth" for its performance is established through adherence to recognized international standards (ASTM, ISO) for physical and chemical properties. These standards define the test methodologies and acceptance criteria.
Therefore, the "experts" involved are the organizations and committees that develop and validate these standards, and the personnel in testing laboratories who are qualified to perform these standard tests. The document does not specify the number or qualifications of individual experts who directly established the "ground truth" for this specific device's test set.

4. Adjudication method for the test set:

For physical and chemical property testing (e.g., watertight, tensile strength), the "adjudication method" is the direct comparison of test results against the established quantitative acceptance criteria defined in the relevant ASTM and ISO standards. There is no mention of a human adjudication process (like 2+1 or 3+1) for these types of objective 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:

This is a medical device (examination glove) and not an AI-powered diagnostic or assistive tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study to assess improvement with AI assistance is not applicable and was not conducted.

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

Again, this is an examination glove, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not conducted.

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 objective technical specifications and test methods outlined in international standards (ASTM D3578, ASTM D5712, ASTM D6124, ASTM D412, ASTM D5151, ISO 10993).
For biocompatibility, the ground truth is established by passing standard biocompatibility test criteria (e.g., for not being sensitizers or irritants), which are laboratory tests.

8. The sample size for the training set:

This is a manufactured physical good. The concept of a "training set" in the context of machine learning or AI is not applicable here. There is no algorithm being trained. Manufacturing processes are optimized through quality control and adherence to specifications, not a training set.

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

As explained in point 8, the concept of a "training set" is not relevant to this type of device. The "ground truth" for the device's performance is established through adherence to the objective criteria of the specified ASTM and ISO standards during manufacturing and quality control.

Summary

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

PREVENTIVE CARE, INC.

510 (k) SUMMARY

DATE: June 10th, 2013

1. Submitter

Preventive Care, Inc. 15215, Boulder Trail Rosemount, MN 55068 Tel: 651 322 9120 Fax: 651 322 9196 E Mail: anil@preventivecareinc.com JUL 2 4 2013

2. Contact Person

Contact: Anil Segat Tel: 651 322 9120 Fax: 651 322 9196 E Mail: anil@preventivecareinc.com

3. Name of device

Trade name: Exam Perfect Powderfree Latex Examination Gloves Coated with Allogel® Common Name: Exam Gloves Classification Name: Patient Examination Glove Classification Number: Class 1 Regulation Number: 21 CFR 880.6250 Product code: LYY

4. Legally Marketed Device to which equivalency is claimed: K110102

Powderfree Nitrile Examination Gloves Coated with Allogel®, LZA, Class 1, that meets or exceeds all the applicable requirements of ASTM standards and FDA water leak test.

5. Device Description

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

6. Intended use of the Device

An Examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger, to prevent contamination between the patient and examiner.

7. Summary of the technological characteristics of the Device

The device meets all the applicable technical requirements of :

ASTM D3578Version 2010	Standard specifications for rubber examination gloves. Data of an actual representativeshipment is detailed in Section 14 (original submission).		ASTM D3578 -2010STANDARD REQUIREMENT	POWDER FREE LATEX EXAMGLOVES COATED WITH ALLOGEL®RESULTS
ASTM D5712Version 2010	Standard test method for analysis of aqueous extractable protein in natural rubber andits products using the modified lowry method. Data of an actual representativeshipment is detailed in Section 14 (original submission).	1. Watertight (1000ml)In accordance with ASTM D5151	Multiple NormalIn accordance with ISO 2859Version 10-2006GI AQL2.5	Pass G1 AQL 2.5
ASTM D6124Version 2006	Standard test method for residual powder on medical gloves. Data of an actualrepresentative shipment is detailed in Section 14 (original submission).	2. Length (mm)Size XSSMLXL	Min 220Min 220Min 230Min 230Min 230	240 mm minimum for all sizes
ASTM D412Version 06ae2	Test method for vulcanized rubber and thermoplastic rubbers and thermoplasticelastomers-tension. Data of an actual representative shipment is detailed in Section 14(original submission).	3. Palm Width (mm)Size XSSMLXL	70 ± 1080 ± 1095 ± 10110 ± 10120 ± 10	75 - 8083 - 8494 - 96107-109113-114
ASTM D5151Version 2006	Standard test method for detection of holes in medical gloves. Data of an actualrepresentative shipment is detailed in Section 14 (original submission).	4. Thickness (mm)(Single Layer)FingerPalmCuff	Min 0.05Min 0.05Min 0.05	Min 0.12Min 0.10Min 0.08
ISO 10993Version 2010	Biological evaluation of medical devices Part 10, tests for skin irritation andsensitization. The test reports are detailed in section 8 & 9 (original submission). Thegloves have passed the biocompatibility test criteria for not being sensitizers or irritants.	5. Physical PropertiesIn accordance with ASTM D 412Before AgingTensile Strength(MPa)Ultimate Elongation (%)After AgingTensile Strength(MPa)Ultimate Elongation (%)	Min 14Min 500Min 14Min 400	18 - 31530 - 60018-29500-550
6. Powder ContentIn accordance with ASTM D6124	Max 2.0mg/glove	Below 2.0mg/glove
7. Residual Latex Proteins	Max 200 micro grams/dm2	Max 200 micro grams/dm2

The above are the principal technical standards that the device needs to comply with. The device has substantially enhanced physical properties as compared to those required by ASTM and other relevant standards.

8. Substantial Equivalence

The substantial equivalence to the predicate device is based on non clinical assessment data. A comparison was made of the physical properties and characteristics of both devices for the following attributes, which were found to be substantially similar:

a. A glove made from natural or synthetic rubber
b. Use and description

c. Physical properties such as, length, width, thickness, tensile strength, freedom from holes, and residual powder. Although the predicate device made from synthetic rubber has no residual natural rubber proteins, the applicant device made of natural rubber complies with the requirements of ASTM D3578 for the maximum allowable residual proteins. The tensile strength and elongation of the applicant device was found to be superior. The thickness of the applicant device was marginally more than the predicate device, but this is normal for latex examination gloves used for medical purposes and it is within the tolerance levels for such devices.

d. Inner coating made from Allogel®

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

9. Physical Performance data

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

10. Substantial equivalence comparison table

	APPLICANT	PREDICATE (K110102)
	PATIENT EXAMINATIONGLOVE	PATIENT EXAMINATIONGLOVE
INICATIONS OF USE
AMBIDEXTROUS	YES	YES
OVER THE COUNTER USE	YES	YES
SINGLE USE	YES	YES
NON STERILE	YES	YES
POWDERFREE	YES	YES
POSITIVE BIOCOMPATABILITY TEST RESULTS	NON IRRITANTNON SENSITIZER	NON IRRITANTNON SENSITIZER
PRIMARY RAW MATERIAL	NATURAL RUBBER	SYNTHETIC NITRILE RUBBER
COATED WITH ALLOGEL®	YES	YES
ALLOGEL® FORMULATION AND PROCESS,CONTROLLED BY PREVENTIVE CARE, INC.	YES	YES
PRIMARY LABEL	ALLOGEL®POWDERFREELATEX EXAMINATION GLOVES	ALLOGEL®POWDERFREENITRILE EXAMINATIONGLOVES
SPECIFICATIONS AND PERFORMANCE
TENSILE STRENGTH BEFORE AGING MINIMUM	18 MPA	14 MPA
APPLICANT PERFORMANCE (see VOL_014_001)	18 MPA
AFTER AGING AT 70 DEG C 7 DAYS. MINIMUM	14 MPA	14 MPA
APPLICANT PERFORMANCE (see VOL_014_001)	17 MPA
ULTIMATE ELONGATION BEFORE AGING MIN.	650%	500%
APPLICANT PERFORMANCE (see VOL_014_001)	797%
AFTER AGING AT 70 DEG C 7 DAYS. MINIMUM	500%	400%
APPLICANT PERFORMANCE (see VOL_014_001)	753%
WIDTH AT PALM (MEDIUM) +/- 5 MM	95 MM	95 MM
APPLICANT PERFORMANCE (see VOL_014_001)	98 MM
LENGTH (MEDIUM) +/- 5 MM	245	245 MM
APPLICANT PERFORMANCE (see VOL_014_001)	241 MM
THICKNESS AT PALM MINIMUM	0.08 MM	0.07 MM
APPLICANT PERFORMANCE (see VOL_014_001)	0.11 MM
THICKNESS AT FINGER MINIMUM	0.08 MM	0.07 MM
APPLICANT PERFORMANCE (see VOL_014_001)	0.13 MM
THICKNESS AT CUFF MINIMUM	0.08 MM	0.07 MM
APPLICANT PERFORMANCE (see VOL_014_001)	0.08 MM
DETECTION OF PIN HOLES (ASTM D5151)	AQL 2.5 MAX	AQL 2.5 MAX
APPLICANT PERFORMANCE (see VOL_014_001)	AQL 1.5
RESIDUAL POWDER	2 MG/GLOVE	2 MG/GLOVE
APPLICANT PERFORMANCE (see VOL_014_001)	0.58 MG/GLOVE (MEDIUM)
MINIMUM SHELF LIFE	3 YEARS	3 YEARS

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

MANUFACTURING PROCESS
CONTINUOUS LINKED CHAIN DIP TECHNOLOGY	YES	YES
ALLOGEL ® DIP PROCESS	YES	YES
PRINCIPAL MATERIALS USED IN THE DIPPROCESS FOR CLEANING, COAGULATING,HEATING AND DRYING ARE THE SAME	YES	YES

11. Substantial equivalence summary discussion & conclusion

The gloves covered by this application are deemed to be substantially equivalent to the predicate, K110102, Powderfree Nitrile Examination gloves coated with Allogel®. Comparisons between the applicant and this predicate device indicate substantial equivalence, in that both:

1. Have the same indication of use
1. Are Powderfree Patient Examination Gloves
1. Do not show any adverse results in bio compatibility tests
1. Are non sterile and are sold over the counter
1. Are coated with Allogel® on the inside
1. Have similar performance specifications and physical properties
1. Meet pin hole AQL requirements as per ASTM D5151 version 2006
1. Are ambidextrous

Are manufactured using a continuous linked chain dip technology with the usage of similar chemicals

1. Use a primary raw material that has properties of Rubber (natural/synthetic)
1. Have similar shelf life

The data and explanations provided above, both for the applicate device, illustrates that there are no substantial differences in the use, physical properties and characteristics of the devices. We can therefore conclude that the two devices are substantially equivalent. The applicant devise is therefore as safe, as effective and performs as well as, or better than the predicate device.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol.

Public Health Service

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

July 24, 2013

Preventive Care, Incorporated Mr. Anil Segat President 15215 Boulder Trail ROSEMOUNT MN 55068

Re: K130667

Trade/Device Name: Powder- Free Latex Examination Glove Coated with AlloGel® Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: 1 Product Code: LYY Dated: April 24, 2013 Received: April 25, 2013

Dear Mr. Segat:

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.

{6}------------------------------------------------

Page 2 - Mr. Segat

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 (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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/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/Safetw/ReportalProblem/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/Resources/orYou/Industry/default.htm.

Sincerely yours.

DAGRID

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director

FOR

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use Form

510(k) Number (if known): K130667

Device Name: : Powder-Free Latex Examination Gloves Coated with AlloGel®

Indications for Use:

An Examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger, to prevent contamination between the patient and examiner.

Prescription Use _ _ _ _ _ _ AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(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)

Sreekanth Gutala -S 2013.07.22 14:24:51 =04'00'

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(k) Number: ماما 30(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.