(228 days)
Not Found
No
The device is a standard medical examination glove and the summary contains no mention of AI, ML, or related technologies.
No
Explanation: This device, nitrile examination gloves, is intended to prevent contamination and does not treat or alleviate a disease or condition.
No
Explanation: The device, nitrile examination gloves, is intended to prevent contamination between the patient and examiner and does not perform any diagnostic function.
No
The device is a physical product (nitrile examination gloves) and the summary describes physical properties and performance testing related to the material and construction of the gloves, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are "worn on the examiner's hand to prevent contamination between the patient and examiner." This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the material (nitrile) and compliance with a standard for examination gloves (ASTM D6319-00a). This standard relates to the physical properties and safety of the glove itself, not to any diagnostic capability.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening
- Using reagents or other diagnostic components
The information provided describes a medical device used for protection and hygiene during medical and dental procedures.
N/A
Intended Use / Indications for Use
The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Powdered Nitrile Medical Examination Gloves meets the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data of gloves is based on ASTM D6319-00a.
Key results based on ASTM D6319-00a:
- Detection of Holes (ASTM 5151): Pass G1 AQL = 2.5*
- Length (mm): 240 mm minimum for all sizes *
- Palm Width (mm): 73-78 (XS), 83-88 (S), 93-98 (M), 104-109 (L), 111 - 118 * (XL)
- Thickness (mm): Min 0.06 (Finger), Min 0.05 * (Palm)
- Physical Properties:
- Before Aging: Tensile Strength (Mpa) 18 - 33, Ultimate Elongation (%) 500 - 630*
- After Aging: Tensile Strength (Mpa) 18 - 33, Ultimate Elongation (%) 500 - 610 *
- Powder Content: Max 120mg/glove *
- Primary Skin Irritation CPSC Title 16 Chapter II Part 1500: PII was "0.04"*
- Dermal Sensitization Test ISO 10993-10: Score was "0"*
Biocompatibility Testing:
- Primary Skin Irritation (study report # MB-PSI-26-09) and Dermal Sensitization Test (study report # MB-DSAb-26-09) completed to CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 standards.
- Conclusion: no irritation or hypersensitivity to the subject gloves (NitriTech® Non-Sterile Powdered Nitrile Examination Gloves in the color blue).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510K Summary
510K: K093516
JUN 29 2010
1. Information
| a. Submitter's | |
|---|---|
| Name: | Summit Glove Inc. |
| Address: | 310 South Grant Street |
| Minerva, Ohio 44657 | |
| Phone: | 330-868-0066 |
| Contact Person: | James Moore |
| E-mail: | jmoore@summitglove.com |
2. Name of Device
| Trade or Proprietary Name: | NitriTech®, Non-Sterile Powdered Nitrile Examination Glove in the color blue |
|---|---|
| Common or Usual Name: | Synthetic Rubber Examination Gloves |
| Classification Name: | Patient Examination Glove, Powdered |
- Predicate Device: Non-Sterile Powder Free Nitrile Examination Gloves Submission Number: K090828. Based on the below test results, it is concluded the subject gloves are a substantial equivalent to the predicate device.
4. Identification of the Legally Marketed Devices
Powdered Nitrile Examination Gloves as described in this 510K Notification is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LZA (21CFR 880.6250). It meets the current specifications listed under the ASTM Specification D6319-00a, Standard for Nitrile Gloves for Medical Application.
5. Description of Device
Powdered Nitrile Medical Examination Gloves meets the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application.
6. Intended Use of Gloves
This is a disposable device intended for medical purposes: that is worn on the examiner's hand, to prevent contamination between the patient and examiner.
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7. Summary of Performance Data:
Performance data of gloves based is on ASTM D6319-00a. ASTM D6319-00a Section 9 is inapplicable for non-sterile examination grade nitrile gloves.
:
| Test | ASTM 6319-00a | Powdered Nitrile Examination Gloves | |
|---|---|---|---|
| 1. Detection of Holes (ASTM 5151) | Multiple Normal G1 AQL = 2.5 | Pass G1 AQL = 2.5* | |
| 2. Length (mm) | |||
| Size XS | Min 220 - | 240 mm minimum for all sizes * | |
| S | Min 220 - | ||
| M | Min 230 - | ||
| L | Min 230 - | ||
| XL | Min 230 | ||
| 3. Palm Width (mm) | |||
| Size XS | 70 ± 10 | 73-78 | |
| S | 80 ± 10 | 83-88 | |
| M | 95 ± 10 | 93-98 | |
| L | 110 ± 10 | 104-109 | |
| XL | 120 ± 10 | 111 - 118 * | |
| 4. Thickness (mm) | |||
| Finger | Min 0.05 | Min 0.06 | |
| Palm | Min 0.05 | Min 0.05 * | |
| 5. Physical Properties | |||
| Before Aging | |||
| Tensile Strength (Mpa) | Min 14 | 18 - 33 | |
| Ultimate Elongation (%) | Min 500 | 500 - 630* | |
| After Aging | |||
| Tensile Strength (Mpa) | Min 14 | 18 - 33 | |
| Ultimate Elongation (%) | Min 400 | 500 - 610 * | |
| 6. Powder Content | Maximum is not Stated | Max 120mg/glove * | |
| 7. | Primary Skin Irritation CPSC | ||
| Title 16 Chapter II Part 1500 | PII Greater or equal to 5.0 | ||
| indicates an irritate | PII was "0.04"* | ||
| 8. | Dermal Sensitization Test ISO | ||
| 10993-10 | Score greater or equal to | ||
| 1 indicates | |||
| irritation/hypersensitivity | Score was "0"* |
- Third Party test data is available in Appendix A
·
:
2
The performance data of the gloves as shown above meet the ASTM D6319-00a Standard using the following test methods:
- o ASTM D412 Tensile Properties Unaged Test Method A
- o ASTM D573 Tensile Properties Aged
- o ASTM D5151 Detection of Holes
- o ASTM D6124-06 Section 7 Procedure II for Powdered Gloves
-
- The Biocompatibility Test consists of Primary Skin Irritation (CPSC Title 16 Chapter II Part 1500) and Dermal Sensitization Tests (ISO 10993-10).
- Third Party test data is available in Ammendment E
The conclusion of the Biocompatibility Testing would indicate that there is no irritation or hypersensitivity to the subject gloves (NitriTech® Non-Sterile Powdered Nitrile Examination Gloves in the color blue).
9. Conclusion:
It is concluded that the NitriTech® Non-Sterile Powdered Nitrile Examination Gloves in the color blue for this submission meets ASTM D6319-00a, CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 requirements.
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Statement concerning the Biocompatibility Testing
The gloves tested in the Biocompatibility Testing were the subject glove (NitriTech®, Non-Sterile Powdered Nitrile Examination Gloves in the color blue) of this submission. Mediamal Testing and Consultancy Services had the Primary Skin Irritation (study report # MB-PSI-26-09) and Dermal Sensitization Test (study report # MB-DSAb-26-09) completed to CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 standards.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. James Moore Project Coordinator Summit Glove, Incorporated 310 South Grant Street Minerva, Ohio 44657
JUN 2 9 2010
Re: K093516
Trade/Device Name: NitriTech® Non-Sterile Powdered Nitrile Medical Examination Gloves in the color blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 10, 2010 Received: June 15, 2010
Dear Mr. Moore:
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. Moore
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/CentersQffices/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/ReportalProblem/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,
Susan Wunner
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): K093516
Device Name: NitriTech® Non-Sterile Powdered Nitrile Medical Examination Gloves in the color blue.
Indications For Use:
The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner.
AND/OR Over-The-Counter Use _ Prescription Use X (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)
f
(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices
K093516 510(k) Number: _