(185 days)
Not Found
No
The device is a sterile nitrile examination glove, a physical barrier device, and the summary provides no indication of any software, data processing, or AI/ML components.
No.
This device is described as a disposable glove intended to prevent contamination, not to treat or cure any medical condition.
No
Explanation: The device is a patient examination glove, intended to prevent contamination between patient and examiner. It does not perform any diagnostic function such as detecting, diagnosing, or monitoring a disease or condition.
No
The device description clearly states it is a physical glove made from acrylonitrile-butadiene copolymer dispersion, and the performance studies focus on physical properties and biocompatibility, 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 patient and examiner." This is a barrier function, not a diagnostic function.
- Device Description: The description focuses on the material, color, powder status, sterilization, and sizing of the gloves. It does not mention any components or functions related to testing samples from the human body.
- Performance Studies and Key Metrics: The performance studies and key metrics are all related to the physical properties, integrity, and biocompatibility of the gloves (length, width, thickness, tensile strength, holes, residual powder, irritation, sensitization, etc.). These are relevant to a barrier device, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any of those functions.
N/A
Intended Use / Indications for Use
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free. Both Gamma & ETO sterilized gloves are available in X-Small, Small, Medium, Large & X-Large sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hand or finger
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purpose)
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)
Non-Clinical Testing Summary:
- ASTM D6319-2019 Standard Specification for Nitrile Examination Gloves for Medical Application: Determined length, width, thickness, and physical properties (tensile strength and ultimate elongation) of the gloves. Results met acceptance criteria for all sizes.
- ASTM D5151-2019 Standard Test Method for Detection of Holes in Medical Gloves: Determined holes in the gloves. Result: Gloves Passes AQL 1.5.
- ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves: Determined residual powder in the gloves. Results met acceptance criteria (≤2 mg/glove).
Biocompatibility Data:
- ISO 10993-10 Biological Evaluation of Medical Devices Test for Skin Irritation and Skin Sensitization (Irritation): Determined potential to produce dermal irritation in Rabbits. Result: Under the condition of study not an irritant.
- ISO 10993-10 Biological Evaluation of Medical Devices Test for Irritation and Skin Sensitization (Skin Sensitization): Determined skin sensitization potential in Guinea Pig. Result: Under the conditions of the study not a sensitizer.
- ISO 10993-5:2009 biological evaluation of medical devices - part 5, tests for in vitro cytotoxicity: Evaluated in vitro cytotoxic potential of test item extracts in L-929 mouse fibroblasts cells. Result: Under the conditions of the study cytotoxic.
- ISO 10993-11:2017 biological evaluation of medical devices - part 11, tests for systemic toxicity: Determined acute systemic toxicity potential of test item extracts in Swiss Albino mice. Result: Under the conditions of study the device extracts do not pose a systemic toxicity concern.
- Material Mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41: Determined pyrogenic potential of test item extract following intravenous injection in New Zealand white Rabbits. Result: Under the conditions of the study, the device did not demonstrate a material mediated pyrogenicity response.
- Bacterial Endotoxin test USP 42: Determined bacterial Endotoxin limit in the glove. Result:
§ 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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 17, 2022
Amazing Rubber Products Pvt Ltd % Manoj Zacharias Consultant Liberty Management Group Ltd 75 Executive Dr. STE 114 Aurora, Illinois 60504. USA
Re: K212586
Trade/Device Name: Sterile Nitrile Patient Examination Gloves Powder Free Blue Color Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: January 19, 2022 Received: January 19, 2022
Dear Manoj Zacharias:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212586
Device Name
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color
Indications for Use (Describe)
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
Type of Use (Select one or both, as applicable)
| Registration Use (Part 21 CFR 601 Subpart D) | |
|---|---|
| One-Time Stockpile Use (21 CFR 601 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510 K SUMMARY K212586 As required by: 21CFR§807.92(c)
A. APPLICANT INFORMATION 510(K) Owner's Name Amazing Rubber Products Pvt. Ltd. Address Plot No 14c, Cochin Special Economic Zone , Kakkanad, Cochin-682 037, Kerala- India 9447053062 Phone ----------Fax E-mail info@aaazingglove.com Contact Person Mr. Jayasankar. S Designation Executive Director Contact Number 9447053062 Contact Email info@aaazingglove.com Date Submitted 14 January 2022
B. DEVICE IDENTIFICATION
| Name of the device | Sterile Nitrile Patient Examination Gloves Powder Free
Blue Color |
|-----------------------------------|----------------------------------------------------------------------|
| Product proprietary or trade name | Amazing+ |
| Common or usual name | Exam Gloves |
| Classification name | Patient Examination Gloves |
| Device Classification | Class-1 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Review Panel | General Hospital |
C. PREDICATE DEVICE
| Predicate Device | Sancare Sterile Nitrile Patient Examination
Gloves, Powder free Blue Colour |
|------------------|--------------------------------------------------------------------------------|
| 510(K) Number | K171093 |
| 510 (K) Owner | Sanrea Healthcare Products Pvt. Ltd. |
| Regulatory Class | 1 |
| Product code | LZA |
D. DESCRIPTION OF THEDEVICE:
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250).The gloves are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free. Both Gamma & ETO sterilized gloves are available in X-Small, Small, Medium, Large & X-Large sizes.
E. INTENDED USE OF THE DEVICE:
Sterile Nitrile Patient Examination Gloves Powder Free Blue Color is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
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F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATEDEVICE
| Characteristics | Standards | Device Performance | Remarks | |
|---|---|---|---|---|
| Predicate | Subject | |||
| 510(K) Number | K171093 | K212586 | --- | |
| Name of device | Sancare Sterile Nitrile | |||
| Patient Examination | ||||
| Gloves, Powder free | ||||
| Blue Colour | Sterile Nitrile Patient | |||
| Examination Gloves | ||||
| Powder free Blue | ||||
| Color | Similar | |||
| Dimensions | ASTM D6319- 2019 | Length Min 230 m | ||
| Width Min 95+/-10 | ||||
| mm(for medium | ||||
| size) | Length Min 230 mm | |||
| Width Min 95+/-10 | ||||
| mm(for medium size) | Same | |||
| Physical Properties | ASTM D6319- 2019 | Before Aging | ||
| Tensile Strength | ||||
| min 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| min 14 Mpa Ultimate | ||||
| Elongation | ||||
| Min 400% | Before Aging | |||
| Tensile Strength min | ||||
| 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 500% | ||||
| After Aging | ||||
| Tensile Strength | ||||
| min 14 Mpa | ||||
| Ultimate Elongation | ||||
| Min 400% | Same | |||
| Thickness | ASTM D6319-2019 | Palm min 0.05 mm | ||
| Finger min 0.05 mm | Palm min 0.05 mm | |||
| Finger min 0.05 mm | Same | |||
| Powder Residue | ASTM D6214 | ≤2 mg/glove | ≤2 mg/glove | Same |
| Primary Skin | ||||
| Irritation- | ||||
| ISO 10993- | ||||
| 10:2010(E) | Under the condition of | |||
| study not an irritant | Under the condition | |||
| of study not an | ||||
| irritant | Same | |||
| Biocompatibility | Dermal | |||
| Sensitization- ISO | ||||
| 10993-10:2010( E) | Under the conditions of | |||
| the study not a sensitizer | Under the conditions | |||
| of the study not a | ||||
| sensitizer | Same | |||
| In vitro cytotoxicity | ||||
| ISO10993-5 | ||||
| :2009(E) | No data available | Under the conditions | ||
| of the study, | ||||
| cytotoxic | ---- | |||
| Acute Systemic | ||||
| Toxicity Test ISO | ||||
| 10993-11:2017(E) | No data available | Under the condition | ||
| of study do not pose | ||||
| a systemic toxicity | ||||
| concern | ---- | |||
| Material Mediated | ||||
| Pyrogenicity ISO | ||||
| 10993-11:2017(E) / | ||||
| USP 41 | No data available | Under the conditions | ||
| of the study non | ||||
| pyrogenic | ---- | |||
| Bacterial Endotoxin | ||||
| test | ||||
| USP 42 | No data available | To determine the pyrogenic | ||
| potential of the test item | ||||
| extract following intravenous | ||||
| injection in New Zealand | ||||
| white Rabbits. | Under the | |||
| conditions of the | ||||
| study, the device | ||||
| did not | ||||
| demonstrate a | ||||
| material mediated | ||||
| pyrogenicity | ||||
| response. | Under the conditions of | |||
| the study, the device did | ||||
| not demonstrate a | ||||
| material mediated | ||||
| pyrogenicity response. | ||||
| Bacterial Endotoxin test | ||||
| USP 42 | To determine the bacterial | |||
| Endotoxin limit in the glove | NMT20 EU/pair of | |||
| gloves |