(391 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of a medical glove, with no mention of AI or ML.
No
Explanation: The device is a "patient examination glove" intended to "prevent contamination between patient and examiner." Its function is protective and diagnostic in nature, not therapeutic.
No
Explanation: The device, a patient examination glove, is intended to prevent contamination between patient and examiner. Its function is a barrier, not to diagnose any condition or disease.
No
The device described is a physical medical device (a patient examination glove) and does not involve any software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is "worn on the examiner's hand or finger to prevent contamination between patient and examiner." This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description focuses on the physical properties and barrier function of the glove, referencing standards for examination gloves. It does not describe any mechanism for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
- Reagents or assay components
The device is a medical device, specifically a patient examination glove, intended for barrier protection.
N/A
Intended Use / Indications for Use
A 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.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
Powder Free Black Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
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
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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic . toxicitv
- ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves .
- ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application .
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Freedom of Holes: Meet AQL 1.5 with G1
Overall Length: Average : 242mm
Width:
S : 85 mm
M : 95 mm
L : 104 mm
Palm Thickness: Average : 0.06mm
Finger Thickness: Average : 0.11mm
Tensile Strength (before age): Average : 17.44 MPa
Tensile Strength (After Age): Average : 16.37 MPa
Ultimate Elongation before age: Average : 559%
Ultimate Elongation after age: Average : 508%
Residual powder test:
S : 0.43 mg/glove
M : 0.31 mg/glove
L : 0.47 mg/glove
Primary Skin Irritation: Under the conditions of study, not an irritant
Dermal Sensitization: Under the conditions of study, not a sensitizer.
Cytotoxicity: Cytotoxic
Acute Systemic Toxicity: Not induce systemic toxicity
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 24, 2021
Vietglove Corporation Terence Lim Quality Assurance & Regulatory Affairs Manager Cau Sat Hamlet, Lai Hung Commune, Bau Bang District, Binh Duong Province Bingh Duong, Bingh Duong Province 72600 Viet Nam
Re: K201428
Trade/Device Name: Powder Free Black Nitrile Examination Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: May 25, 2021 Received: May 27, 2021
Dear Terence Lim:
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.
1
Page 2
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 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 medical devices and radiation-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 Ryan Ortega, Ph. D Acting 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
2
Indications for Use
510(k) Number (if known) K201428
Device Name POWDER FREE BLACK NITRILE EXAMINATION GLOVE
Indications for Use (Describe)
A 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.
| 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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3
510 (K) SUMMARY
K201428
| 1.0 | Submitter | Vietglove Corporation | |
|---|---|---|---|
| Cau Sat Hamlet, Lai Hung Commune |
Cau Sat Hamlet, Lai Hung Commune Bau Bang District Binh Duong Province
| Tel: | +84-650-591220 |
|---|---|
| Fax: | +84-650-591220 |
2.0
Name of Contact Person: Terence Lim Email Address: limsinkooi@@gmail.com Date of Summary Prepared: May 17, 2021
3.0 Name of Device:
510(k) number K201428 Trade Name: Powder Free Black Nitrile Examination Glove Classification Name: Polymer Patient Examination Glove Device Classification: 21 CFR 880.6250 Regulation Number: General Hospital Panel: Product Code: LZA
4.0 Identification of The Legally Marketed Device
Predicate Device Name: Powder Free Blue Nitrile Examination Glove
Predicate 510(K) Number: K153562
Manufacturer's Name: VIETGLOVE CORPORATION
5.0 Description of Device
Powder Free Black Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
6.0 The Intended Use/Indications for Use
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
7.0 Summary of the Technological Characteristic of the Device compared to the Predicate Device for Substantial Equivalent Discussion.
4
VIETGLOVE CORPORATION
Cau Sat Hamlet, Lai Hung Commune, Bau Bang District ,Binh Duong Province Vietnam
There is no difference in technology characteristic compared to the predicate device. Gloves are made from nitrile latex compound. Non-Sterile, Powder Free Blue Nitrile Examination Gloves has the below technological characteristic compared to ASTM or Equivalent standards.
Comparison On Technological Characteristic Between The Predicate Device And Subject Devices
| Characteristics and
Parameters | Proposed Device -
Powder Free Nitrile
Examination Gloves
(K201428) | Predicate Device -
Powder Free Blue
Nitrile Examination
Gloves (K153562 ) | Discussion |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| Product Code | LZA | LZA | Same product Code |
| Intended
Use
/
Indications for Use | A patient examination
glove is a disposable
device intended for
medical purposes that
is worn on the hand or
finger to prevent
contamination between
patient and examiner. | A patient examination
glove is a disposable
device intended for
medical purposes that
is worn on the hand or
finger to prevent
contamination
between patient and
examiner. | Same Intended Use. |
| Classification | Class 1 | Class 1: | Same Class. |
| Raw Rubber Material | Nitrile (Acrylonitrile-
butadiene) | Nitrile (Acrylonitrile-
butadiene) | Same synthetic rubber
material. |
| Surface Appearance | 1.Black
2. Ambidextrous
3.Finger Textured | 1.Blue
2. Ambidextrous
3.Finger Textured | 1. Different color
2. Same ambidextrous
design
3. Same texture area. |
| Freedom of Holes
Meet AQL 2.5 at G1 | Meet AQL 1.5 with
G1 | Meet AQL 1.5 with
G1. | Similar |
| Overall Length
Minimum 230mm | Average : 242mm | More than 230mm | Similar |
| Width
S : 75mm - 95mm
M: 85mm - 105mm
L: 100mm – 120mm | Average :
S : 85 mm
M : 95 mm
L : 104 mm | Meeting
specification | Similar |
| Palm Thickness
(Minimum 0.05mm) | Average : 0.06mm | More than 0.05mm | Similar |
| Finger Thickness
(Minimum 0.05mm) | Average : 0.11mm | More than 0.05mm | Similar |
| Tensile Strength
(before age)
Minimum 14 MPa | Average : 17.44 MPa | More than 14 MPa | Similar |
| Tensile Strength
(After Age)
Minimum 14 MPa | Average : 16.37 MPa | More than 14 MPa | Similar |
| Characteristics and
Parameters | Proposed Device -
Powder Free Nitrile
Examination Gloves
(K201428) | Predicate Device -
Powder Free Blue
Nitrile Examination
Gloves (K153562 ) | Discussion |
| Ultimate Elongation
before age
(Minimum 500%) | Average : 559% | Minimum 500% | Similar |
| Ultimate Elongation
after age
(Minimum 400%) | Average : 508% | Minimum 400% | Similar |
| Residual powder test
(Less than
2mg/glove) | Average powder
residue for each size:
S : 0.43 mg/glove
M : 0.31 mg/glove
L : 0.47 mg/glove | Contained less than
2mg/glove | Similar |
| Primary Skin Irritation | Under the conditions
of study, not an
irritant | Under the conditions
of study, not an
irritant | Similar |
| Dermal Sensitization | Under the conditions
of study, not a
sensitizer. | Under the conditions
of study, not a
sensitizer. | Similar |
| Cytotoxicity | Cytotoxic | N/A | Different |
| Acute Systemic
Toxicity | Not induce systemic
toxicity | N/A | Meeting the requirements
per ISO 10993-11 |
5
VIETGLOVE CORPORATION
Cau Sat Hamlet, Lai Hung Commune, Bau Bang District ,Binh Duong Province Vietnam
Summary of Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic . toxicitv
- ASTM D6124-06, Standard Test Method for Residual Powder on Medical Gloves .
- ASTM D5151-06, Standard Test Method for Detection of Holes in Medical Gloves. ●
- ASTM D6319-10, Standard Specification for Nitrile Examination Gloves for Medical Application .
- ISO 2859-1:1999, "Sampling Procedures for Inspection by Attributes Part I: Sampling Plans ● Indexed by Acceptable Quality Level (AQL) for Lot-by-Lot Inspection.
Clinical Test Conclusion
No clinical test is included in this submission.
Conclusion
The conclusion drawn from the nonclinical tests demonstrates the subject device in 510(K) submission K201428, Powder Free Black Nitrile Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153562.