(204 days)
A 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.
The Powdered, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.
This document describes the technical characteristics and performance of "Powdered, Natural Color, Latex Examination Gloves, Non-Sterile" produced by Best Putra Gloves Sdn Bhd. It serves as a 510(k) summary for clearance by the FDA.
1. Acceptance Criteria and Reported Device Performance
The device is assessed against ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test. The table below outlines the specific characteristics and their performance:
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimensions | D 3578-01a€ | Meets |
| Physical Properties | D 3578-01a€ | Meets |
| Freedom from Pinhole | D 3578-01a€, FDA CFR 800.20 | Meets |
| Powder Amount | D 3578-01a€, D 6124 - 05 | <10 mg/dm- |
| Water Soluble Protein Content | D 3578-01a€, D 5712-99 | <200 ug/dm² |
| Biocompatibility | Primary Skin Irritation in Rabbits | Pass (No primary skin irritation) |
| Dermal Sensitization | Pass (No contact sensitizer) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test in the "Device Performance" section. However, it indicates that the tests were performed on the device itself. The provenance of the data is not specified in terms of country of origin or whether it's retrospective or prospective. Given the context of a 510(k) submission, these tests would typically be performed prospectively by the manufacturer or a contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable. The "ground truth" for this device, which refers to ideal design parameters and performance, is established by recognized consensus standards (ASTM D 3578-01a22) and regulatory requirements (FDA 1000 ml Water Leak Test and FDA CFR 800.20 for pinholes), not by expert consensus on individual cases.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in clinical studies where expert review is needed for ambiguous cases. In this case, device performance is objectively measured against predefined quantitative and qualitative standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is not relevant for the type of device (examination gloves) or the nature of its evaluation, which focuses on material properties, physical dimensions, and barrier integrity rather than diagnostic interpretation.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
This information is not applicable. The device is a physical product (examination gloves), not an algorithm or AI system. Therefore, the concept of "standalone performance" in the context of AI does not apply.
7. Type of Ground Truth Used
The ground truth used for evaluating this device's performance is derived from established industry standards and regulatory requirements. Specifically, this includes:
- ASTM standard D 3578-01a22: This standard specifies the requirements for latex examination gloves, covering dimensions, physical properties, and freedom from pinholes.
- FDA 1000 ml Water Leak Test: A regulatory requirement for assessing the integrity and barrier performance of gloves against pinholes.
- FDA CFR 800.20: Regulations pertaining to medical devices, specifically for pinholes in gloves.
- D 6124 - 05: Standard test method for assessing powder on medical gloves.
- D 5712-99: Standard test method for the analysis of protein in natural rubber and its products.
- Biocompatibility tests: These tests (Primary Skin Irritation in Rabbits, Dermal Sensitization) are standard toxicological assessments to ensure the material does not cause adverse biological reactions.
8. Sample Size for the Training Set
This information is not applicable. The concept of a "training set" belongs to machine learning and AI development, which are not relevant to the evaluation of this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no training set for this type of device evaluation.
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Image /page/0/Picture/0 description: The image shows the letters BPG in a bold, sans-serif font. The letters are large and take up most of the frame. The letters are black, and the background is white. The letters are slightly distressed, with some small imperfections and rough edges.
I PUTRA GLUVES SUN.BHD. (580515-T)
& 1358, Jin Kg. Mohd Taib, Kawas 3000 Rawang, Selangor Da +03-6092 1042 +03-6092 1142 Fax: +0 E-mail : bog@streamyx.com Website
Image /page/0/Picture/3 description: The image contains two sets of logos. The first set includes the "nqa. ISO 9001 Registered" logo and the "UKAS ENVIRONMENTAL MANAGEMENT 015" logo. The second set includes the "nqa. ISO 14001 Registered" logo and the "UKAS ENVIRONMENTAL MANAGEMENT 015" logo.
<101106
510 (K) SUMMARY
1.0 Submitter:
NOV 1 0 2010
0143
| Name | : Ratnam S.Vythilingam |
|---|---|
| Address | : Best Putra Gloves Sdn Bhd, Jln Kg Mohd Taib, Kawasan Perindustrian Sg Choh, 48000, Rawang, Selangor Darul Ehsan. Malaysia |
| Phone No. | : +03-60921042 |
| Fax No. | : +03-60912820 |
Date of Summary Prepared: 20 August 2010
2.0 Contact Person:
| Name | Dr. Effendi Tenang |
|---|---|
| Phone No. | +03-60921042 |
| Fax No. | +03-60912820 |
3.0 Name of the device:
| Trade Name | : 1) BPG Latex Examination Gloves2) Multiple or Customers' Trade Name |
|---|---|
| Device Name | : Powdered, Natural Color, Latex Examination Gloves,Non-Sterile |
| Common Name | : Examination Gloves |
| Classification Name | : Patient Examination Gloves (Class 1) |
4.0 Identification of the legally marketed device:
Class I patient examination gloves, powdered, that meets all the requirements of
ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.
5.0 Description of the Device:
The Powdered, Natural Color, Latex Examination Gloves, Non-Sterile meets all the requirements of ASTM standard D 3578-01a22 and FDA 1000 ml Water Leak Test.
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Image /page/1/Picture/0 description: The image shows the letters 'BPG' in a bold, sans-serif font. The letters are black and have a slightly distressed or textured appearance, giving them a rough or worn look. The letters are large and take up most of the frame.
(580515-1)
Lot 1357 & 1358, Jln Kg. Mohd Taib, Kawasan Perindustrian Sg. Choh
48000 Rawang, Selangor Darul Ehsan, Malaysia.
Tel: +03-6092 1042, +03-6092 1142 Fax: +03-6091 2820
E-mail : bpg@streamyx.com Website : www.bpgloves.com
Image /page/1/Picture/2 description: The image contains two sets of logos related to quality and environmental management systems. The first set includes the "nqa. ISO 9001 Registered" logo and the "UKAS" logo with the number "015" below it. The second set includes the "nqa. ISO 14001 Registered" logo and the "UKAS" logo with the number "015" below it. The logos suggest that the organization has been certified for both ISO 9001 (quality management) and ISO 14001 (environmental management) standards by an accredited body.
6.0 Intended Use of the Device:
A 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.
7.0 Summary of the technological characteristic of the devices:
The Powdered, Natural Color, Latex Examination Gloves, Non-Sterile are summarized with following technological characteristics compared to ASTM or equivalent standards.
| CHARACTERISTICS | STANDARDS | DEVICEPERFORMANCE |
|---|---|---|
| Dimensions | D 3578-01at | Meets |
| Physical Properties | D 3578-01a€ | Meets |
| Freedom from Pinhole | D 3578-01a84 | Meets |
| FDA CFR 800.20 | ||
| Powder Amount | D 3578-01a64 | <10 mg/dm- |
| D 6124 - 05 | ||
| Water Soluble Protein | D 3578-01a84 | <200 ug/dm² |
| Content | D 5712-99 | |
| Biocompatability | Primary Skin | Pass |
| Irritation in Rabbits | (No primary skin irritation) | |
| Dermal Sensitization | Pass | |
| (No contact sensitizer) |
8.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data.
The performance test data of the non-clinical tests that support a determination of substantial equivalent is the same as mentioned immediately above.
9.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data.
Clinical data is not needed for gloves or for most devices cleared by the 510 (k) process.
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Image /page/2/Picture/0 description: The image shows the letters 'BPG' in a bold, sans-serif font. The letters are black and have a distressed or grunge texture, giving them a worn or aged appearance. The letters are large and take up most of the frame.
BESI PUIKA GLOVES SDN.BHD. (580515-T)
Lot 1357 & 1358, Jin Kg. Mohd Taib, Kawasan Perindustrian Sg. Choh 48000 Rawang, Selangor Darui Ehsan, Malaysia. Tel: +03-6092 1042, +03-6092 1142 Fax: +03-6091, 2820 E-mail : bpg@streamyx.com Website : www.bpgloves.com
Image /page/2/Picture/3 description: The image contains two sets of logos related to quality and environmental management systems. The first set includes the "nqa. ISO 9001 Registered" logo alongside the UKAS (United Kingdom Accreditation Service) environmental management logo with the number 015. The second set features the "nqa. ISO 14001 Registered" logo, also accompanied by the UKAS environmental management logo with the same number 015, indicating certification or registration under these standards.
K101106
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10.0 Conclusion
It can be concluded that the Powdered , Natural Color, Latex Examination Gloves, Non-Sterile will perform according to the glove performance standards referenced in Section (7) above and meet ASTM standards, and FDA requirements for Water Leak Test on pinhole AQL. Consequently, this device is substantially equivalent to currently marketed devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Effendi Tenang Managing Director Best Putra Gloves SDN BHD Lot 1357-1358, JLN Kg. Mohd Taib Kawasan Perindustrian Sg. Choh 48000 Rawang, Selangor Darul Ehsan, Malaysia
NOV 1 0 2010
Re: K101106
Trade/Device Name: Powdered, Latex Examination Gloyes, Natural Color, Non-Sterile Model: MEP1 Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: October 4, 2010 Received: October 21, 2010
Dear Dr. Tenang:
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.
Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.
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Page 2- Dr. Tenang
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/Resourcesfor You/Industry/default.htm.
Sincerely vours,
Seren Luures
Anthony D. 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
Enclosure .
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Image /page/5/Picture/0 description: The image shows the letters "BPG" in a bold, sans-serif font. The letters are large and take up most of the frame. The letters are solid black, and the background is white.
T PUTRA GLOVES SDN.BF
Lot 1357 & 1358, Jln Kg. Mohd Taib, Kawasan Perindustrian Sg. Choh,
48000 Rawang, Selangor Darul Ehsan, Malaysia.
Tel: +03-6092 1042, +03-6092 1142 Fax: +03-6091 2820
E-mail: bpg@streamyx.com Website: www.bpgloves.com
Image /page/5/Picture/3 description: The image shows two sets of logos. The first set includes a logo with the text "nga. ISO 9001 Registered" and another logo with a checkmark and the number "015". The second set includes a logo with the text "ISO 14001 Registered" and another logo with a checkmark and the number "015".
1 0 2019
INDICATIONS FOR USE
510( k ) Number: K101106
Device Name: Powdered, Latex Examination Glove, Natural Color, Non-Sterile, Model: MEP1
Indications For Use:
A 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.
Sincerely
Dr. Effendi Tenang
(Managing Director)
Prescription Use_ (Part 21 CFR 801 Subpart D)
OR
Over - The - Counter Use XXX (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of _
Elaine S. Mayhall
Offision Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital
Seneral Section of Anesthesionogy, General Devices Division of Anesthoolor
510(k) Number: K101106
§ 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.