A powdered Patient Examination Glove is a disposable device made of natural rubber latex or symthetic material that bears powder to facilitate donning and is intended to be worn on the hand or finger(s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Device Description

Patient Examination Glove, Powdered (with protein labeling claims claims 300 micrograms or less)

AI/ML Overview

This device is a Powdered Latex Patient Examination Glove with Protein Label Claims (300 micrograms or less). As such, it is a Class I medical device and its performance is assessed against established physical and chemical specifications, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested categories are not applicable.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Specification)	Unit	Reported Device Performance (Compliance)
Overall Length	mm minimum	Meets (230 mm minimum)
Width (for medium Glove)	mm minimum	Meets (95 mm minimum)
Palm Thickness	mm minimum	Meets (0.08 mm minimum)
Finger Thickness	mm minimum	Meets (0.08 mm minimum)
Tensile Strength (before aging)	MPa minimum	Meets (18 MPa minimum)
Tensile Strength (after aging)	MPa minimum	Meets (14 MPa minimum)
Ultimate Elongation (before aging)	% minimum	Meets (650% minimum)
Ultimate Elongation (after aging)	% minimum	Meets (500% minimum)
Pinhole AQL (@70C for 7 days)	-	Meets (2.5)
Protein Label Claims	micrograms or less	Meets (300 micrograms or less)
Adherence to ASTM Standard Specification D3578-05	-	Meets all current specifications
Specialty/Chemotherapy Claims	-	No claims for this use
Former Release Powder or Chemical	-	None used

The document states, "The data for this examination glove meets all of the current specification listed under ASTM Standard Specification D3578-05." This statement directly confirms that the device meets the established acceptance criteria.

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

Test Set Sample Size: Not explicitly stated. The specifications provided (e.g., AQL for pinholes, physical properties) are typically derived from a statistically significant sample as defined by the ASTM standard referenced (D3578-05). However, the specific number of gloves tested for each parameter is not included in this summary.
Data Provenance: Not explicitly stated beyond the manufacturing location (Eufaula, Alabama, U.S.A.). It is assumed that the testing was conducted by the manufacturer or a certified lab on samples produced at this location. It is retrospective in the sense that the data was collected prior to the 510(k) 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 a medical device (glove) whose performance is evaluated through physical and chemical testing against established standards, not through interpretation by human experts. The "ground truth" is defined by the ASTM standard D3578-05.

4. Adjudication method for the test set

Not Applicable. As there are no human interpretations involved in determining glove performance against physical specifications, no adjudication method (like 2+1, 3+1 consensus) is needed.

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/software device, and its performance is not assessed through human reader studies.

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

Not Applicable. This is not an AI/software device. Its performance is the standalone performance of the physical glove.

7. The type of ground truth used

Established Industry Standard (ASTM D3578-05). The ground truth for the device's performance is defined by the quantitative physical and chemical specifications outlined in the ASTM Standard Specification D3578-05 for patient examination gloves.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not a machine learning model. Therefore, there is no "training set."

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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

K080606

AUG - 7 2008

510(K) Summary (K08606) Powdered Latex Patient Examination Glove with Protein Label Claims (300 Micrograms or less)

Name Alatech Healthcare LLC 1600, State Docks Rd, Eufaula Alabama 36027 U.S.A. Phone Number (334) 688-8520

Registration Number 3005627398

Activity of Applicant Manufacturer

Contact Person at Firm Neil Anderson RAC

(334) 688- 8520 Phone Number

Email raexprt@yahoo.com

Truthful and Accurate Statement

Indications for Use

Name and Location of Actual Manufacturer

Alatech healthcare LLC 1600, State Docks Road Eufaula Alabama 36027 USA

Phone Number (334) 688-8520

Label, Labeling and Advertising

Fax (334) 688- 8521

Fax (334) 688-8521

See Appendix 1

See Appendix II

Fax (334) 688-8521

See Appendix III

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

K080606

Device Classification

Class 1

Substantial Equivalence device Description

Patient Examination Glove, Powdered (with protein labeling claims claims 300 micrograms or less) Predicate device K050527 Powdered Latex Examination Glove with Protein Labeling Claim, ( 300 micrograms or less) Manufacturer-SPI Gloves, 5 Persiaran Greentown 8, Greentown Business Center, 39450 Ipoh, Perak, Darul Ridzuan, MALAYSIA

Product Code Latex 80-LYY

Specifications

Overall Length

230 mm minimum

Width

Palm Thickness

Finger Thickness

Tensile Strength

Ultimate Elongation

Pinhole AQL

95 mm minimum (for medium Glove)

0.08 mm minimum

18 MPa minimum (before aging)

14 MPa minimum (after aging)

650% minimum (before aging)

500% minimum (after aging)

2.5 (@70C for 7 days)

The data for this examination glove meets all of the current specification listed under ASTM Standard Specification D3578-05

Specialty, Chemotherapy Gloves

These gloves are not claimed to be for Specialty or Chemotherapy use.

Former Release Powder or Chemical

None used.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three distinct, curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Neil Anderson R.A.C Manager of Regulatory Affairs Alatech Healthcare, LLC 1600 State Docks Road Eufaula, Alabama 36027

AUG - 7 2008

Re: K080606

Trade/Device Name: Powdered Latex Patient Examination Glove with Protein Label Claims (300 micrograms or less) Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: July 11, 2008 Received: July 21, 2008

Dear Mr. Anderson:

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 such 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.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mannels Lend, n.d. for 11

Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Appendix II

Indications for Use

Alatech Healthcare LLC Applicant Name K080606 510(k) Number Powdered Latex Patient Examination Glove with Device Name Protein Label Claims (300 micrograms or less)

Prescription use (21CFR 801 subpart D) Over the Counter (21CFR. subpart C

Concurrence of CDRH Office of Device Evaluation

Shiela A Murphy, MD

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

510(k) Number: K080616

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.