(120 days)
An examination glove is a disposable device intended for medical and examination purposes that is worn on the examiner's hand to prevent contamination between the examiner and the patient or substance handled
Powderfree Nitrile Examination Gloves coated with Allogel®, in colors Blue, Magenta or Copper, is a disposable device worn on the hand of a healthcare or similar personnel, to prevent contamination between the wearer of the glove and the person or substance handled
The provided document describes the acceptance criteria and performance data for "Powderfree Nitrile Examination Gloves Coated with Allogel®".
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D6319 Standard) | Reported Device Performance (Powder Free Nitrile Exam Gloves Coated with Allogel®) |
|---|---|---|
| Watertight (1000ml) (ASTM D 5151) | Multiple Normal in accordance with ISO 2859 GI AQL=2.5 | Pass GI AQL = 2.5 |
| Length (mm) | 240 mm minimum for all sizes | |
| - Size XS | Min 220 | |
| - Size S | Min 220 | |
| - Size M | Min 230 | |
| - Size L | Min 230 | |
| - Size XL | ||
| 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 |
| - Before Aging: Ultimate Elongation (%) | Min 500 | 530 - 600 |
| - After Aging: Tensile Strength (MPa) | Min 14 | 18 - 29 |
| - After Aging: Ultimate Elongation (%) | Min 400 | 500 - 550 |
| Powder Content (ASTM D6124) | Max 2.0 mg/glove | Below 2 mg/glove |
| Biocompatibility Tests | Not Sensitizers or Irritants | Passed criteria of not being Sensitizers or Irritants |
| - Primary Skin Irritation Test | Passed | |
| - Guinea Pig Sensitization (Buehler) test | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- The document states "Data of an actual representative shipment is detailed in Section 14" for various physical property tests, but Section 14 is not provided in the input. Therefore, the specific sample size for the test set is not explicitly stated in the provided text.
- Data Provenance: The document does not specify the country of origin of the data. It indicates the data is from an "actual representative shipment," suggesting prospective data collection from manufacturing batches.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not applicable to this type of device (examination gloves). The performance is assessed against established ASTM standards and FDA watertightness requirements, not expert consensus on an interpretation.
4. Adjudication Method for the Test Set
- This information is not applicable. No adjudication method involving human interpretation is described as the tests are objective measurements against pre-defined standards.
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
- An MRMC comparative effectiveness study is not applicable to this device. This type of study is used for diagnostic AI systems, not for physical examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is not applicable. The device is a physical product (examination glove), not an algorithm or AI system. Its performance is assessed through laboratory testing, not algorithmic output.
7. The Type of Ground Truth Used
- The ground truth used for performance evaluation are established industry standards and regulatory requirements:
- ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- FDA Water Leak Test (likely based on ASTM D5151)
- ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- Biocompatibility test criteria (not specified in detail but states "not being Sensitizers or Irritants").
8. The Sample Size for the Training Set
- This information is not applicable. There is no "training set" for physical product testing against objective standards. The gloves are manufactured and then samples are tested for conformance.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reason as above. There is no training set mentioned or implied for this type of device.
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110102
MAY 1 3 2011
PREVENTIVE CARE, INC.
510(k) SUMMARY
-
- Submitter: Preventive Care, Inc. 15215, Boulder Trail Rosemount, MN 55068, USA
-
- Contact Name: Anil Segat
-
- Phone: 651 322 9120
-
- Fax: 651 322 9196
- ട്. E Mail: anil@preventivecareinc.com
- January 1000, 2011 6. Date of Preparation:
-
- Device
,
| Trade Name: | Powderfree Nitrile Examination Gloves Coated with Allogel®, Blue, Magenta, Copper |
|---|---|
| Common Name: | Examination Glove |
| Classification name: | Patient Examination Glove (Class1) |
-
- Identification of legally marketed devices to which Equivalency is claimed:
- ರು. Intended use of device:
10. Summary of technological Characteristics compared to Predicate device:
Class 1 Powderfree Nitrile Examination Gloves, coated with Allogel®, colored, 80LZA, that meets all the applicable requirements of ASTM D6319-2010 and FDA water leak test Powderfree Nitrile Examination Gloves coated with Allogel®, in colors Blue, Magenta or Copper, is a disposable device worn on the hand of a healthcare or similar personnel, to prevent contamination between the wearer of the glove and the person or substance handled
There are no different technological characteristics compared to the predicate devices (detailed in Section 2 Form 3514) to which substantial equivalency is sought. They are all non sterile powderfree nitrile examination gloves (one coated with Allogel® Magenta color), with equivalent performance characteristics.
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KI10102
11. Performance Data
Performance data of gloves based on ASTM D6319 and FDA Watertight test
| TEST | ASTM D6319STANDARDREQUIREMENT | POWDER FREE NITRILE EXAMGLOVES COATED WITHALLOGEL® |
|---|---|---|
| RESULTS | ||
| 1. Watertight (1000ml) inaccordance with ASTMD 5151 | Multiple Normal inaccordance with ISO 2859 | |
| GIAQL=2.5 | Pass GIAQL = 2.5 | |
| 2. Length (mm) | ||
| SizeXS | Min 220 | 240 mm minimum for all sizes |
| S | Min 220 | |
| M | Min 230 | |
| L | Min 230 | |
| XL | ||
| 3. Palm Width (mm) | ||
| SizeXS | 70 ± 10 | 75 - 80 |
| S | 80 ± 10 | 83 - 84 |
| M | 95 ± 10 | 94 - 96 |
| L | 110±10 | 107 - 109 |
| XL | 120±10 | 113 - 114 |
| 4. 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 |
| 5. Physical PropertiesIn accordance withASTM D 412 | ||
| Before Aging | Min 14 | 18 - 31 |
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| Tensile Strength(MPa)Ultimate Elongation (%) | Min 500 | 530 - 600 |
|---|---|---|
| After AgingTensile Strength(MPa)Ultimate Elongation (%) | Min 14Min 400 | 18 - 29500 - 550 |
| 6. Powder Content inaccordance with ASTMD6124 | Max 2.0mg/glove | Below 2 mg/glove |
- The performance data of the glove as shown above meets the requirements of ASTM D6319, A. • including the Residual Powder requirement of max 2 mg per glove. Data of an actual representative shipment is detailed in Section 14
- The performance data above show that the Powderfree Nitrile Examination Gloves coated with B. : Allogel®, meet ASTM D 6319 requirements for Dimensions and Tolerances. Data of an actual representative shipment is detailed in Section 14
- ্ The performance data above show that the gloves meet ASTM D 6319 requirements of properties tested in accordance with ASTM D 412. Data of an actual representative shipment is detailed in Section 14
- D. The Biocompatibility Tests consist of (1) Primary Skin Irritation Test and (2) Guinea Pig Sensitization (Buehler) test. The test reports are detailed in Sections 8&9 The gloves have passed the Biocompatibility Test criteria of not being Sensitizers or Irritants.
- 12. Conclusion
.
We concluded that the Multiple Private Labeled, Powderfree Nitrile Examination Gloves coated with Allogel® in colors Blue, Magenta or Copper meet the requirements of:
- ASTM D-6319 and FDA requirements for:
- ੋ Watertight test for pinholes
- ் Physical properties
- 0 Dimensions
- ্ Residual Powders
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Image /page/3/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 symbol, with three curved lines representing the wings and body. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY 1 3 2011
Ms. Anil Segat President Preventive Care, Incorporated 15215 Boulder Trail Rosemount, Minnesota 55068
Re: K110102
Trade/Device Name: Powder-Free Nitrile Examination Gloves Coated with AlloGel® (Blue/Magenta/Copper) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 18, 2011 Received: March 24, 2011
Dear Ms. 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.
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Page 2- Ms. 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 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,
hn for
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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Indications for Use Form
510(k) Number (if known): K110102
Device Name: : Powder-Free Nitrile Examination Gloves Coated with AlloGel® (Blue/Magenta/Copper)
Indications for Use:
An examination glove is a disposable device intended for medical and examination purposes that is worn on the examiner's hand to prevent contamination between the examiner and the patient or substance handled
Prescription Use _____________________________________________________________________________________________________________________________________________________________
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)
Ellyabeth A. Clamitz Will
(ivision Sign-Off)
of Anesthesiology, General Hospital fection Control, Dental Devi
Page 1 of __ 1
510(k) Number: K110102
§ 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.