A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's for the expected contamination between patient and examiner. This device is for over-the counter use.
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.

Device Description

Non Sterile Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-05, Standard Specification for Nitrile Examination Gloves for Medical Application.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Non-Sterile, Blue Color Powder Free Nitrile Examination Glove":

This document describes a 510(k) summary for a medical device, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device. For such devices, the "acceptance criteria" are generally compliance with recognized standards and performance specifications, and the "study" is the testing conducted to show this compliance.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Standard)	Reported Device Performance
Watertight (1000ml)	FDA 1000ml Water Leak Test: AQL = 2.5	Pass
ASTM D6319-05:
Length (mm) - Size M, L, XL	Min 230	240 - 248
Palm width (mm) - Size M	95 ± 10	95 - 98
Finger Thickness (mm) (Single Layer)	Min 0.05	0.08 - 0.09
Palm Thickness (mm) (Single Layer)	Min 0.05	0.06 - 0.07
Physical Properties (Before Aging):
Tensile Strength (MPa)	Min 14	22 - 32
Ultimate Elongation (%)	Min 500	710 - 750
Physical Properties (After Aging):
Tensile Strength (MPa)	Min 14	22 - 29
Ultimate Elongation (%)	Min 400	630 - 690
Powder Content	Max 2.0mg/glove	Below 2 mg/glove
Moisture Content	Max 2.0%	0.57%
Bio-compatibility (Primary Dermal Irritation Test, Guinea Pig Sensitization)	Pass (implied standard, though not explicitly stated as ASTM)	Pass

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

The document does not explicitly state the specific sample sizes for each test within the "Summary of Performance Data." However, for gloves, industry standards like ASTM D6319-05 typically specify sampling plans (e.g., AQL levels for attributes like watertightness). The "Multiple Normal G1" indicated for the Watertight test likely refers to a sampling plan for inspection level G1.

The data provenance is from Malaysia (BIOGREEN YIELDS SDN. BHD. is located in Sitiawan, Perak, Malaysia). The nature of the tests (physical and chemical properties, bio-compatibility) indicates this data is prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for this submission.

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

This type of device (patient examination gloves) does not typically involve human expert interpretation for establishing "ground truth" in the way an AI diagnostic algorithm would. The "ground truth" is established by direct measurement of physical and chemical properties and biological reactions according to standardized protocols (ASTM D6319-05, FDA watertight test, bio-compatibility tests). Therefore, there were no human experts establishing ground truth in the context of interpretation; rather, qualified laboratory personnel would have conducted the tests according to established scientific methods.

4. Adjudication method for the test set

Not applicable for this type of device testing. Adjudication is relevant for subjective interpretations, often in diagnostic imaging, where multiple experts may disagree. Here, the tests are 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

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI-assisted diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a physical product (gloves) and does not involve AI or human "readers" in its performance evaluation.

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

No, a standalone study (in the context of AI algorithms) was not done. This device is a physical product and its performance is measured directly against established physical and chemical standards, not through an AI algorithm.

7. The type of ground truth used

The ground truth used is based on:

Performance Standards/Specifications: Established by recognized standards organizations (ASTM D6319-05) and regulatory bodies (FDA 1000ml watertight test).
Objective Measurements: Direct quantitative and qualitative measurements of physical properties (length, width, thickness, tensile strength, elongation), chemical properties (powder content, moisture content), and biological reactions (bio-compatibility tests).

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in the machine learning sense. The manufacturing process itself (which is subject to Good Manufacturing Practices) ensures consistency, but there's no data set used to "train" the product's performance.

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

Not applicable. As there is no training set for this physical device, there is no ground truth established for a training set.

Summary

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Ki0016.2

BIOGREEN YIELDS SDN. BHD. Lot 1422, Batu 10 Lekir 32020 SITIAWAN, PERAK, MALAYSIA

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MAR 2 4 2010

510(k) SUMMARY

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BIOGREEN YIELDS SON. BHD. LOT 1422, BATU 10 LEKIR 32020 SITIAWAN, PERAK, MALAYSIA

510 (K) SUMMARY SHEETS
------------------------

1.0
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	SMDA 510 (K) SUMMARY
2.0 Submitter	BIOGREEN YIELDS SDN. BHD.,Lot 1422, Batu 10 Lekir• 32020 Sitiawan, PerakMalaysia
Tel	605-6792288
Fax	605-6791188
Name of Contact Person	1. Mr. Tiong Chiong Kieng2. Mr. Arivalagan
Date of Summary Prepared	January 5, 2010

3.0 Name of Device

Trade Name: Non-Sterile, Blue Color Powder Free Nitrile Examination Glove

Common Name: Synthetic Rubber Examination Gloves

Classification Name: Patient Examination Glove, Powder Free

4.0 Identification of The Legally Marketed Devices

Non Sterile Powder Free Nitrile Examination Gloves as described in this 510k Notification is substantially equivalent to the current Class I patient examination glove bearing the product Specification DC310 06, School Specifications listed under the prove Specification D6319-05, Standard Specification for Nitrile Gloves for Medical Application.

5.0 Description of The Device

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BIOGREEN YIELDS SDN. BHD. Lot 1422, Batu 10 Lekir

32020 SITIAWAN, PERAK, MALAYSIA

6.0 The Intended Use of Glove

7.0 Summary of Performance Data:

Performance data of gloves based on ASTM D6319-05 and FDA 1000ML watertight test.

Test	FDA 1000ml Water LeakTest	Powder Free Nitrile ExaminationGloves
	Multiple Normal
1. Watertight (1000ml)	GIAQL = 2.5	Pass
Test	ASTM D6319-05
2. Length (mm)SizeMLXL	Min 230Min 230	240 - 248
3. Palm width (mm)SizeM	95 ± 10	95 - 98
4. Thickness (mm)(Single Layer)
FingerPalm	Min 0.05Min 0.05	0.08 - 0.090.06 - 0.07
5. Physical Properties
Before AgingTensile Strength (MPa)Ultimate Elongation (%)	Min 14Min 500	22 - 32710 - 750
After AgingTensile Strength (MPa)Ultimate Elongation (%)	Min 14Min 400	22 - 29630 - 690
6. Powder Content	Max 2.0mg/glove	Below 2 mg/glove
7. Moisture Content	Max 2.0%	0.57%

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BIOGREEN YTELDS SDN. BHD. LOT 1422, BATU 10 LEKIR 32020 SITIAWAN, PERAK, MALAYSIA

8.0 The performance data of the glove as shown above meet the ASTM D6319-05 Standard and FDA's requirement. Powder content is below 2 mg per glove which meet the FDA Requirements.
9.0 The Bio-compatibility Test consists of Primary Dermal Irritation Test and Guinea Pig Sensitization (Buehler) test. The gloves pass the Bio-compatibility Test.
10.0 Conclusion

We conclude that the Non-Sterile, Blue Color Powder Free Nitrile Examination Gloves meets:

. ASTM D6319-05 Standard
. FDA pinhole requirements
Are below the maximum Powder Residual Content as specified in ASTM D6319-05

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Image /page/4/Picture/1 description: The image contains the logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird in flight, rendered in blue. The overall design is clean and professional, representing the department's role in public health and welfare.

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

MAY 20 2010

Mr. Tiong Chiong Kieng Director Biogreen Yields Sdn. Bhd Lot 1422 Batu 10 Lekir Sitiawan Perak MALAYSIA 32020

Re: K100162

Trade/Device Name: Non Sterile, Blue Color Powder Free Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 5, 2010 Received: January 20, 2010

Dear Mr. Kieng:

This letter corrects our substantially equivalent letter of March 24, 2010 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 (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. Kieng

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 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,

Susan Rusner

Anthony Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K100162

Indications for Use

510(k) Number (if known): K100162

Device Name: Non Sterile, Blue Color Powder Free Nitrile Examination Gloves

Indications For Use:

A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ 1 (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)

signature

Page 1 of

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

510(k) Number: _ |< | 0 0 | 6 2

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.