(313 days)
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent contamination between the examiner and the patient.
The subject device of this submission is a Nitrile Examination Glove. The glove is non-sterile and meets the recommendations of ASTM 6319-10. The device is Blue in color.
This document is a 510(k) Premarket Notification for Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue. It demonstrates substantial equivalence to a predicate device (K112012). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance specifications of the glove and the testing conducted to show compliance with those specifications and equivalence to the predicate device.
Here's an breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents several characteristics and their corresponding standards/performance for the new device (K162510) and the predicate device (K112012). This can be structured as follows:
| Characteristic | Standard/Acceptance Criteria (for New Device) | Reported Device Performance (New Device K162510) | Reported Predicate Device Performance (K112012) |
|---|---|---|---|
| Dimensions | ASTM D 6319-10; Inspection Level-S-2 AQL 4.0 | Inspection Level-S-2 AQL 4.0 | Not explicitly stated as pass/fail; Implicitly meets the same general standard. |
| Physical Properties | ASTM D 6319-10; Inspection Level-S-2 AQL 4.0 | Inspection Level-S-2 AQL 4.0 | Not explicitly stated as pass/fail; Implicitly meets the same general standard. |
| Freedom from Pinholes – Water Tight Test (1000ML) | ASTM D 6319-10; ASTM D 5151-06; Inspection Level-G-1 AQL 1.5 | Inspection Level-G-1 AQL 1.5 | AQL 1.5 |
| Powder-Free Residue | ASTM D 6319-10; ASTM D 6124-06; Maximum 2mg/glove | Maximum 2mg/glove (Avg 1.0mg/glove) | Max 2.0mg/glove (Avg .22mg/glove) |
| Biocompatibility - Dermal Sensitization | Dermal Sensitization (as per ISO 10993-10); Not a contact skin sensitizer | Not a contact skin sensitizer | Non-sensitizer |
| Biocompatibility - Primary Skin Irritation | Primary Skin Irritation Test (as per 16 CFR Part 1500); Not a primary skin irritant | Not a primary skin irritant | Non-irritating |
| Tensile Strength (MPa) | ASTM D3578-05(2015); Before Aging: min 14.0; After Aging: min 14.0 | Before Aging: min 14.0; After Aging: min 14.0 | Before Aging: min 14.0; After Aging: min 14.0 |
| Elongation (%) | ASTM D3578-05(2015); Before Aging: min 500; After Aging: min 400 | Before Aging: min 500; After Aging: min 400 | Before Aging: min 500; After Aging: min 400 |
| Palm Width (Medium size) | 95mm +/-10 | 95mm +/-10 | 95mm +/- 10 |
| Length | 240mm min | 240mm min | 240mm min |
| Thickness (Palm and Finger) | Min .05mm Palm and finger | Min .05mm Palm and finger | Min .15mm Palm and Min .17mm finger |
| Sizes | XS - XL | XS - XL | XS - XL |
| Single Use | Yes | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document refers to "Inspection Level-S-2" and "Inspection Level-G-1" with associated AQLs (Acceptance Quality Limits) for various tests (e.g., Dimensions, Physical Properties, Freedom from Pinholes). These imply specific sampling plans outlined in the relevant ASTM standards (ASTM D 6319-10, ASTM D 5151-06, etc.). However, the exact number of units tested is not explicitly stated in this summary document.
- Data Provenance: Not explicitly stated in terms of country of origin of the data or whether it was retrospective/prospective. As this is a premarket submission for a physical device, the testing would have been conducted in a lab environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This is not applicable in the context of this device. This document is about a physical medical device (gloves), not an AI/software device requiring expert interpretation of medical images or data. The "ground truth" for glove performance is established by adherence to specified physical and chemical characteristics and recognized ASTM and ISO standards, not by expert consensus on clinical interpretation.
4. Adjudication Method for the Test Set
- Not applicable. The "ground truth" is determined by objective physical and chemical testing methods (e.g., measuring dimensions, tensile strength, performing water leak tests, chemical residue analysis, biocompatibility assays), not through human adjudication of differing interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is relevant for AI/imaging devices where human reader performance is a key metric. For examination gloves, the focus is on physical and chemical properties and safety/performance equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithm or AI device. The "performance" is the inherent physical and chemical properties of the glove.
7. The Type of Ground Truth Used
- The ground truth for this device is based on objective, standardized measurements and test methods defined by recognized national and international standards, primarily ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. This includes:
- Physical Specifications: Dimensions (length, width, thickness), tensile strength, elongation.
- Functional Testing: Freedom from pinholes (water integrity).
- Chemical Analysis: Powder residue.
- Biocompatibility Testing: Dermal sensitization and primary skin irritation, conducted according to ISO 10993-10 and 16 CFR Part 1500.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this is not a machine learning or AI device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
UG Global Resources Sdn. Bhd. % Kenneth Stanton President UG Healthcare (USA) Inc. 1565 Sunflower Ave Costa Mesa, California 92626
Re: K162510
Trade/Device Name: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZA Dated: June 20, 2017 Received: January 19, 2017
Dear Kenneth Stanton:
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.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Mark S. Fellman -S
for
Lori Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162510
Device Name
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
Indications for Use (Describe)
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent contamination between the examiner
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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SUMMARY
PREMARKET 510(k) NOTIFICATION Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue K162510
Submission Applicant:
UG Global Resources Sdn Bhd 1st Floor No. 18 Jalan Dato'Abd Rahman 70000 Seremban Negeri Sembilan Darul Khusus, Malaysia Telephone No .: 60-06-6772751 Fax:60-06-6772755
Official Correspondent: Kenneth J. Stanton, President UG Healthcare (USA) Inc. 1565 Sunflower Avenue Costa Mesa, Ca 92626 Tel: (714)444-2248 Fax: (714)444-2271
Date: June 8, 2017
Description of the Device: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
Trade Name: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
Common Name: Nitrile Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6250) Class 1: Powder-Free Nitrile examination glove LZA that meets all of the requirements of ASTM 6319-10.
Predicative Devices (K112012):Non-Sterile, Powder-Free, Blue, Nitrile Examination Gloves
Device Description: The subject device of this submission is a Nitrile Examination Glove. The glove is non-sterile and meets the recommendations of ASTM 6319-10 . The device is Blue in color.
Indications for Use: Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue 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 the examiner.
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SUMMARY
PREMARKET 510(k) NOTIFICATION
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue
Summary of Technological Characteristics:
Material: Nitrile Cuff: Beaded Powder Residue: Maximum 2mg/glove
| Characteristics | Standards | Device Performance |
|---|---|---|
| Dimensions | ASTM D 6319-10 | Inspection Level-S-2 AQL4.0 |
| Physical Properties | ASTM D 6319-10 | Inspection Level-S-2AQL4.0 |
| Freedom from Pinholes – Water TightTest 1000ML | ASTM D 6319-10ASTM D 5151-06 | Inspection Level-G-1AQL 1.5 |
| Powder-Free Residue- | ASTM D 6319-10ASTM D 6124-06 | Maximum 2mg/glove |
| Biocompatibility | Dermal Sensitization(as per ISO 10993-10) | Not a contact skin sensitizer |
| Primary Skin Irritation Test(as per 16 CFR Part 1500) | Not a primary skin irritant |
Packaging: 100 pieces per dispenser box, 10 boxes per case, 1,000 gloves per case
Sizes: XS -XL
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Substantial Equivalence Table-
| Color | Material | Biocompatibility Tests | ASTM D3578-05(2015)Tensile Strength (MPa) | ASTM D3578-05(2015)Elongation % | |
|---|---|---|---|---|---|
| SubjectDeviceK162510 | Blue | Nitrile | ISO 10993-10 - Primary Irritation Test- Under theconditions of the study, the device is non-irritating | Before Aging- min 14.0 | Before Aging - min500 |
| ISO 10993-10 - Dermal Sensitization Assay -Under the conditions of the study, the device is anon-sensitizer | After Aging - min 14.0 | After Aging - min.400 | |||
| PredicateDeviceK112012 | Blue | Nitrile | ISO 10993-10 - Dermal Sensitization Assay - Underthe conditions of the study, the device is a non-sensitizer | Before Aging- min 14.0 | Before Aging- min.500 |
| ISO 10993-10 - Primary Irritation Test- Under theconditions of the study, the device is non-irritating | After Aging- min 14.0 | After Aging - min.400 |
| Subject Device | Dimensions | Waterleak | Powder Content | ||
|---|---|---|---|---|---|
| K162510 | Palm Width - 95mm +/-10 Medium sizeLength: 240mm minThickness: Min .05mm Palm and finger | AQL 1.5 | Max 2.0mg/gloveAvg 1.0mg/glove | ||
| K112012 | Palm Width- 95mm +/- 10 Medium sizeLength: 240mm minThickness: Min .15mm Palm and Min .17mm finger | AQL 1.5 | Max 2.0mg/gloveAvg .22mg/glove |
| Sizes | Single Use | Indications for Use | |
|---|---|---|---|
| SubjectDeviceK162510 | XS-XL | Yes | A patient examination glove is a disposable device intended for medical purposes that is worn on theexaminer's hand or finger to prevent contamination between patient and examiner |
| PredicateDeviceK112012 | XS-XL | Yes | A patient examination glove is a disposable device intended for Medical Purposes that is worn on theexaminer's hand or finger to prevent contamination between patient and examiner |
Comparisons-Both K162510 and K112012 are Non-Stelle Examination Gloves. Both have the same specifications exept for thickness, both have the same AQ. 1.5 for pinholes and similar powder content. Both gloves have be matility Test. Additionally, both devices have similar tensile strength and elongation performance.
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Conclusion:
This product is as safe, as effective, and performs as well or better than the legally marketed device K112012 (Non-Sterination Gloves),
§ 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.