(69 days)
The 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.
Powder free blue nitrile patient exam glove, meets all the requirements of ASTM standard D6319, except for sterility requirements. Non-sterile, powder free, examination gloves made of nitrile and colored blue. The textured gloves are provided in sizes extra small, small, medium, large and extra large. Non-sterile gloves are provided in dispenser boxes.
The provided text describes a 510(k) summary for the "ETS Blue Powder Free Nitrile Patient Exam Glove," a Class I medical device. The summary focuses on demonstrating substantial equivalence to a predicate device by meeting established performance standards.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Device Performance |
|---|---|---|
| Dimension | ASTM D6319 | Meets |
| Physical Properties | ASTM D6319 | Meets |
| Freedom from Pinholes | ASTM D6319 & ASTM D5151 | Meets |
| Powder Residual | ASTM D6124 | Meets (Results generated values below 2mg of residual powder) |
| Biocompatibility | Primary Skin Irritation in rabbits (ISO 10993-10) | Gloves are non-irritating |
| Biocompatibility | Dermal Sensitization in the guinea pig (ISO 10993-10) | Gloves do not display any potential for sensitization |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the specific tests (e.g., number of gloves tested for dimensions, pinholes, etc.). It only indicates that the device "Meets" the specified ASTM and ISO standards, which inherently include sampling plans within those standards.
- Sample Size: Not explicitly stated for each test. The standards referenced (ASTM D6319, D5151, D6124, ISO 10993-10) would define the required sample sizes for demonstrating compliance.
- Data Provenance: Not explicitly stated. This information is typically generated by the manufacturer or a contracted testing lab during product development and quality assurance. It's retrospective testing of the manufactured product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device. The "ground truth" for patient examination gloves is established by objective, verifiable physical and chemical properties measured against recognized industry standards (ASTM, ISO). There are no human "experts" establishing a subjective ground truth for these performance criteria in the way there would be for, for example, image interpretation in a diagnostic AI study.
4. Adjudication Method for the Test Set
This information is not applicable. As mentioned above, the "ground truth" is determined by objective physical and chemical testing against standards, not by expert consensus or adjudication of subjective interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a Class I medical device (patient examination glove). MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation of complex data (like medical images), where the AI might assist a human reader. This device does not involve that type of interaction or assessment.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This is a physical product (glove), not an algorithm or software device. Standalone performance refers to the accuracy of an AI algorithm on its own.
7. The Type of Ground Truth Used
The ground truth used is based on objective measurements against established national and international standards. Specifically:
- Physical properties (dimensions, tensile strength, ultimate elongation) are measured against ASTM D6319-10.
- Freedom from pinholes is measured against ASTM D5151-06 and D6319-10.
- Residual powder is measured against ASTM D6124-06.
- Biocompatibility (skin irritation and sensitization) is assessed against ISO 10993-10.
8. The Sample Size for the Training Set
Not applicable. This product is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms for this device. The manufacturing process is validated (which might involve statistical process control and testing of batches), but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. (See point 8).
In summary: The provided 510(k) summary for the ETS Blue Powder Free Nitrile Patient Exam Glove demonstrates its safety and effectiveness by showing that it meets recognized consensus standards (ASTM and ISO) for physical characteristics and biocompatibility, thereby establishing substantial equivalence to a legally marketed predicate device. The nature of this device means that many of the AI/algorithm-specific questions are not relevant.
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510(k) SUMMARY
DATE:
OWNER:
February 17, 2012
SEP 10 2012
Northstar Healthcare Holdings 70 Sir John Rogerson's Quay Dublin 2, Ireland
OFFICIAL
CORRESPONDENT:
Alex Nagy Manager, Quality Systems and Regulatory Affairs Cypress Medical Products LLC 1200 South Route 31 McHenry, IL 60050 Telephone: 815-385-0100 Fax: 815-385-0114
DEVICE NAME:
| Trade Name: | ETS Blue Powder Free Nitrile Patient Exam Glove |
|---|---|
| Common Name: | Patient Examination Gloves |
| Classification: | Patient Examination Gloves |
| Class: | Class I |
| Product Code: | LZA |
PREDICATE DEVICE(S):
| Predicate510(k) | Device Name | Indication | ClearanceDate | Company |
|---|---|---|---|---|
| K062764 | Nitrile Powder FreeExamination Gloves(White, Blue) | The patient examination glove is adisposable device intended for medicalpurposes that is worn on the examiner's handto prevent contamination between patient andexaminer. | 27 Feb 07 | KossanLatexIndustriesSDN BHN.SelangorDarulEhsan,Malaysia |
DEVICE DESCRIPTION: Powder free blue nitrile patient exam glove, meets all the requirements of ASTM standard D6319, except for sterility requirements.
Northstar Healthcare Holdings
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STATEMENT OF INTENDED USE:
The nitrile examination glove is a disposable device intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.
TECHNOLOGICAL CHARACTERISTICS: The ETS Blue Powder Free Nitrile Patient Exam Glove is substantially equivalent to the predicate device with regard to physical characteristics, design, product features, and intended use. Both gloves are made with nitrile using similar manufacturing processes.
| Feature | Nitrile Powder Free Examination Gloves Testedfor Use with Chemotherapy Drugs (Blue,White)K062764Predicate | ETS Blue Powder Free NitrilePatient Exam GlovesProposed |
|---|---|---|
| Intended Use | Intended for medical purposes that is worn onthe examiner's hand to prevent contaminationbetween patient and examiner. Tested for Usewith Chemotherapy Drugs. | Intended for medical purposes thatis worn on the examiner's hand toprevent contamination betweenpatient and examiner. |
| Indications for UseStatement | The patient examination glove is a disposabledevice intended for medical purposes that isworn on the examiner's hand to preventcontamination between patient and examiner.This device is not intended to be used as achemical barrier. | The examination glove is adisposable device intended formedical purposes that is worn on theexaminer's hand or finger to preventcontamination between patient andexaminer. |
| Description | Non-sterile, powder free, examination glovesmade of nitrile and colored white. The texturedgloves are provided in sizes extra small, small,medium, large and extra large. The smoothgloves are provided in sizes small, medium,large and extra large. | Same |
| Presentation | Non-sterile gloves are provided in dispenserboxes. | Same |
| Material | Nitrile | Same |
| Sterilization | Non-sterile | Same |
| Single Use | Yes | Same |
| Ambidextrous | Yes | Same |
| Dimensions | Meets ASTM D6319-10 | Same |
| Tensile Strength | Meets ASTM D6319-10 | Same |
| Ultimate Elongation | Meets ASTM D6319-10 | Same |
| Freedom fromPinholes | Meets ASTM D5151-06 and ASTM D6319-10 | Same |
| Residual Powder | Meets ASTM D6124-06 | Same |
| Biocompatibility | Passes Primary Skin Irritation in Rabbits | Same |
| Tests | Passes Closed Patch Sensitization in Guinea Pigs | Same |
Northstar Healthcare Holdings
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ASSESSMENT OF NONCLINICAL DATA:
| Characteristic | Standard | Device Performance |
|---|---|---|
| Dimension | ASTM D6319 | Meets |
| Physical Properties | ASTM D6319 | Meets |
| Freedom from Pinholes | ASTM D6319 & ASTM D5151 | Meets |
| Powder Residual | ASTM D6124 | Meets |
| Results generated values | ||
| below 2mg of residual | ||
| powder | ||
| Biocompatibility | Primary Skin Irritation in rabbits | Gloves are non-irritating |
| (ISO 10993-10) | ||
| Dermal Sensitization in the guinea | Gloves do not display any | |
| pig (ISO 10993-10) | potential for sensitization |
CONCLUSIONS:
The ETS Blue Powder Free Nitrile Patient Exam Gloves meet the requirements of established standards ASTM D6319-10, ASTM D6124-06, ASTM D5151-06, and ISO 10993-10.
Based on the comparison of intended use, design, materials and performance, the ETS Blue Powder Free Nitrile Patient Exam Gloves are substantially equivalent to the predicate device.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Northstar Healthcare Holdings C/O Mr. Ned Devine Senior Staff Engineer Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
SEP 10 2012
Re: K121947
Trade/Device Name: ETS Blue Powder Free Nitrile Patient Exam Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: August 28, 2012 Received: August 28, 2012
Dear Mr. Devine:
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- Mr. Devine
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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
For Q. Shem.D.
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
510(k) Number (if known): _ K 12 1947
ETS Blue Powder Free Nitrile Patient Exam Glove Device Name:
Indications for Use: The 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of Anesthesiology, General Hospital Infection Control, Dental Devices |
Page 1 of _510(k) Number:
§ 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.