(139 days)
Not Found
No
The device is a simple examination glove and the description contains no mention of AI or ML technology.
No.
The device is described as an examination glove intended to prevent contamination, which is a barrier function rather than a therapeutic one.
No
Explanation: The device, O'Star Nitrile Examination Gloves, is described as a disposable glove worn on the examiner's hand to prevent contamination. Its function is protective and barrier-related, not to diagnose medical conditions or provide diagnostic information.
No
The device is a physical product (nitrile examination gloves) and not software. The description focuses on material properties, physical tests, and biocompatibility, which are characteristic of a hardware medical device.
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 test performed in vitro (outside the body).
- Device Description: The description details the material, specifications, and classification of the gloves. It does not mention any components or functions related to analyzing samples or providing diagnostic information.
- 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 specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition.
The device is a Class I medical device intended for barrier protection during medical examinations.
N/A
Intended Use / Indications for Use
O'Star Nitrile Examination Gloves Powder Free 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
O'Star Nitrile Examination Gloves Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 Tests: O'Star Nitrile Examination Gloves Powder Free was subjected to performance tests according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual. These tests included Dimension (Length, Width, and Thickness), Physical property (Tensile strength and Ultimate Elongation), Barrier property tests (Detection of Holes in Medical Gloves), and Powder Free Residue. All tests passed.
Biocompatibility: The materials used were tested for biocompatibility according to ISO 10993-1:2018. Tests performed included Invitro Cytotoxicity, Skin Sensitization, Skin Irritation, and Acute Systemic Toxicity. All tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Detection of Holes in Medical Gloves: AQL=2.5
Powder Free Residue: ≤2 Mg/Glove Max
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.
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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 8, 2022
Star Investment And Trade Joint Stock Company % Manoj Zacharias US Agent Liberty Management Group Limited 75 Executive Drive, Suite 114 Aurora, Illinois 60504
Re: K213058
Trade/Device Name: O'Star Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Non-powdered patient examination glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 8, 2021 Received: September 22, 2021
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213058
Device Name
O'Star Nitrile Examination Gloves Powder Free
Indications for Use (Describe)
O'Star Nitrile Examination Gloves Powder Free 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) |
|---|
| ------------------------------------------------- |
| ☐ Residential Use (24 CFR 881 Subpart D) | ☑ Other Than Subsidized (24 CFR 881 Subpart C) |
|---|---|
| ------------------------------------------ | ------------------------------------------------ |
__ Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for O'Star. The logo features a stylized star shape in shades of green and blue, with the word "O'Star" in blue, with the apostrophe in the same color. The overall design is modern and clean.
STAR INVESTMENT AND TRADE JOINT STOCK COMPANY
Manufacturer address: Khac Niem Industrial Cluster, Khac Niem Ward, Bac Ninh City, Bac Ninh Province, Vietnam. Telephone No: +84 22 23 810 962 Email: ostargloves.business@gmail.com
510(k) SUMMARY (K213058)
[AS REQUIRED BY 21CFR807.92]
I. SUBMITTER
| 510(k) Owner's Name | : | STAR INVESTMENT AND TRADE JOINT STOCK COMPANY |
|---|---|---|
| Address | : | Khac Niem Industrial Cluster, Khac Niem Ward, Bac Ninh City, |
| Bac Ninh Province, 16000, Vietnam | ||
| Telephone | : | +84 22 23 810 962 |
| Contact person | : | DO VAN BINH |
| Designation | : | Chairman & General Director |
| Contact Number | : | +84 984 990 992 |
| Contact Email | : | thutrang.tpp2001@gmail.com |
| Date of Summary Prepared | : | 05.01.2022 |
DEVICE II.
| Brand Name | : O'Star Nitrile Examination Gloves Powder Free |
|---|---|
| Device Common Name | : Nitrile Examination Gloves Powder Free |
| Device Classification name | : Non-powdered patient examination glove |
| Regulation Number | : 21 CFR 880.6250 |
| Class | : I |
| Product Code | : LZA |
III. PREDICATE DEVICE
| Predicate Device Name | Disposable Nitrile Gloves |
|---|---|
| 510(k) Number | K210276 |
| Regulation Number | 21 CFR 880.6250 |
| Class | I |
| Product Code | LZA |
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Image /page/4/Picture/0 description: The image shows the logo for O'Star. The logo features a stylized star shape in green and blue, with the word "O'Star" in blue, with the "O" being larger than the rest of the letters. The star shape is positioned above and to the left of the text.
IV. DEVICE DESCRIPTION
O'Star Nitrile Examination Gloves Powder Free is a Class I device bearing the product code LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color having Finger Texture, Ambidextrous and are powder free. The product is non-sterile.
V. INTENDED USE
O'Star Nitrile Examination Gloves Powder Free is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| SI.
| No | Features compared | Proposed Device | Predicate Device | Result | |||
|---|---|---|---|---|---|---|---|
| General Information | |||||||
| 1. | 510(k) Number | K213058 | K210276 | - | |||
| 2. | Manufacturer | STAR INVESTMENT AND | |||||
| TRADE JOINT STOCK COMPANY | FUJIAN ERCON MEDICAL | ||||||
| MANAGEMENT CO., LTD. | - | ||||||
| 3. | Classification | I | I | Same | |||
| 4. | Regulation number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | |||
| 5. | Product Code | LZA | LZA | Same | |||
| 6. | Indication For Use | O'Star Nitrile Examination Gloves | |||||
| Powder Free is a disposable device | |||||||
| intended for medical purpose that | |||||||
| is worn on the examiner's hand to | |||||||
| prevent contamination | |||||||
| between | |||||||
| patient and examiner. | Disposable Nitrile Examination | ||||||
| Gloves Powder Free is disposable | |||||||
| devices intended | |||||||
| for medical | |||||||
| purpose that are worn on the | |||||||
| examiner's hand to prevent | |||||||
| contamination between patient | |||||||
| and examiner. | Same | ||||||
| 7. | Material | Nitrile | Nitrile | Same | |||
| 8. | Color | Blue | Blue | Same | |||
| 9. | Texture | Finger Texture | Finger Texture | Same | |||
| 10. | Ambidextrous | Yes | Yes | Same | |||
| 11. | Size | S, M, L, XL | S, M, L, XL | Same |
Table 1: General Comparison
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Image /page/5/Picture/0 description: The image shows the logo for O'Star. The logo features a green and blue star above the text "O'Star" in blue. The text is stylized with a wave-like design underneath.
| SI.
| No | Features compared | Proposed Device | Predicate Device | Result |
|---|---|---|---|---|
| 12. | OTC Use | Yes | Yes | Same |
| 13. | Reusability | Single use | Single use | Same |
| 14. | Sterility | Non- sterile | Non- sterile | Same |
| 15. | Dimensions | Length=min 230±10 mm | ||
| Width= min 95±10 mm | ||||
| (For medium size) | Length=min 230±10 mm | |||
| Width= min 95±10 mm | ||||
| (For medium size) | Same | |||
| 16. | Thickness | Palm min 0.05 mm | ||
| Finger min 0.05 mm | Palm min 0.05 mm | |||
| Finger min 0.05 mm | Same | |||
| 17. | Physical Properties | 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 | |||
| 18. | Detection of Holes | AQL=2.5 | AQL=2.5 | Same |
| 19. | Powder Free Residue | ≤2 mg/glove | ≤2 mg/glove | Same |
| 20. | ||||
| Biocompatibility Study | Invitro Cytotoxicity | Under the conditions of the study, | ||
| cytotoxic to L-929 cells. Additional | ||||
| Testing was performed to | ||||
| determine if this was a systemic | ||||
| toxicity concern | Under the conditions of the | |||
| study, not cytotoxic. | Different | |||
| Skin Sensitization | Under the conditions of the study, | |||
| not a sensitizer | Under the conditions of the | |||
| study, not a sensitizer | Same | |||
| Skin Irritation | Under the condition of study not | |||
| an irritant | Under the condition of study not | |||
| an irritant | Same | |||
| Acute Systemic | ||||
| Toxicity | Under the conditions of the study, | |||
| the device extracts do not pose a | ||||
| systemic toxicity concern | Data not available | - |
There are no significant differences between the two products and are identical in terms of intended use, materials, design, manufacturing methods. Both devices meet the ASTM standard D6319-19.
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Image /page/6/Picture/0 description: The image shows the logo for O'Star. The logo features a green and blue star-like shape on the left, followed by the text "O'Star" in blue. The logo has a clean and modern design.
VII. PERFORMANCE DATA
Non- Clinical Data A.
Performance Tests
O'Star Nitrile Examination Gloves Powder Free is subjected to the following performance tests according to the requirements of Guidance for Industry and FDA Staff - Medical Glove Guidance Manual and found to be safe and efficient with respect to its intended use:
- Dimension
- Physical property
- Barrier property tests- Detection of Holes in Medical Gloves
- Powder Free Residue
Table 2: Performance Testing Summary
| SI No. | Tests | Proposed Device actual Data | Acceptance Criteria | Result | ||||
|---|---|---|---|---|---|---|---|---|
| 1. | Dimension | Size | Length | Width | Size | Length | Width | |
| Length, Width and | ||||||||
| Thickness | S | 247.2mm | 90mm | S | 80mm±10 | Pass | ||
| ASTM D6319-19 /ASTM | M | 243.8mm | 103.7mm | M | 230mm min | 95mm±10 | ||
| D412-16/ASTM D3767- | L | 245.5mm | 104.2mm | L | 110mm±10 | |||
| 03-(Reapproved2020) | XL | 247.2mm | 110.2mm | XL | 120mm±10 | |||
| Thickness | Thickness | |||||||
| Standard Specification | Size | Palm | Finger | Size | Palm | Finger | ||
| for Nitrile Examination | S | 0.055mm | 0.052mm | S | ||||
| Gloves for Medical | ||||||||
| Application | M | 0.052mm | 0.053mm | M | 0.05 mm min | 0.05 mm min | ||
| L | 0.053mm | 0.053mm | L | |||||
| XL | 0.057mm | 0.053mm | XL | |||||
| 2. | Physical property | |||||||
| Tensile strength and | ||||||||
| Ultimate Elongation | Tensile strength | Tensile strength | ||||||
| Size | Before | |||||||
| Aging | After | |||||||
| Aging | Size | Before | ||||||
| Aging | After | |||||||
| Aging | ||||||||
| S | 14.23 Mpa | 14.07Mpa | S | Pass | ||||
| M | 15.85 Mpa | 14.09 Mpa | M | 14Mpa Min for | ||||
| all sizes | 14Mpa Min for | |||||||
| all sizes | ||||||||
| ASTM D6319-19/ASTM | L | 14.92 Mpa | 14.13 Mpa | L | ||||
| D573-04 (Reapproved |
-
| XL | 15.32 Mpa | 14.81 Mpa | XL | | | |
| | | Ultimate Elongation | | | Ultimate Elongation | | | |
| | Standard Specification
for Nitrile Examination | Size | Before
Aging | After
Aging | Size | Before
Aging | After
Aging | |
| | Gloves for Medical | S | 702% | 694% | S | | | |
| | Application | M | 935% | 836% | M | 500% Min for
all sizes | 400%Min for
all sizes | |
| | | L | 768% | 728% | L | | | |
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Image /page/7/Picture/0 description: The image shows the logo for O'Star. The logo features a stylized star shape in the upper left corner, with a gradient of green to blue. The text "O'Star" is written in a bold, blue font to the right of the star. The overall design is simple and modern.
| SI No. | Tests | Proposed Device actual Data | Acceptance Criteria | Result |
|---|---|---|---|---|
| 3. | Detection of Holes in | |||
| Medical Gloves | ||||
| ASTM D6319-19 /ASTM | ||||
| D5151-19 | ||||
| Standard Test Method | ||||
| for Detection of Holes | ||||
| in Medical Gloves | AQL=2.5 | AQL=2.5 | Pass | |
| 4. | Powder Free Residue | |||
| ASTM D6124- | ||||
| 06(Reapproved2017) | ||||
| Standard Test Method | ||||
| for Residual Powder on | ||||
| Medical Gloves | Size | |||
| Residual powder content | Size | |||
| Residual powder content | ||||
| S | ||||
| 0.03 mg | S | Pass | ||
| M | ||||
| 0.07 mg | M | |||
| ≤2 Mg/Glove Max | ||||
| L | ||||
| 0.01 mg | L | |||
| XL | ||||
| 0.05 mg | XL |
B. Biocompatibility
The materials used in the O'Star Nitrile Examination Gloves Powder Free are biocompatible based on the biocompatibility tests mentioned in the Guidance for Industry and FDA Staff - Medical Glove Guidance Manual:
- Invitro Cytotoxicity .
- . Skin Sensitization
- . Skin Irritation
- . Acute Systemic Toxicity
These tests are performed according to ISO 10993-1:2018, Biological Evaluation of Medical Devices - Part 1, Evaluation and Testing within a Risk Management Process.
Table 3: Biocompatibility Test Summary
| SI.
| No | Test Performed | Proposed Device | Acceptance Criteria | Result |
|---|---|---|---|---|
| 1. | Invitro Cytotoxicity | Under the conditions of the | ||
| study, cytotoxic to L-929 cells. | ||||
| Additional Testing was | ||||
| performed to determine if this | ||||
| was a systemic toxicity concern | Under the conditions of the | |||
| study, not cytotoxic. | Pass | |||
| 2. | Skin Sensitization | Under the conditions of the | ||
| study not a sensitizer | Under the conditions of the | |||
| study not a sensitizer | Pass |
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Image /page/8/Picture/0 description: The image shows the logo for O'Star. The logo features a stylized star shape in shades of green and blue, with the word "O'Star" in blue, bold font. The star is positioned to the left of the text, and the overall design is clean and modern.
| 3. | Skin Irritation | Under the condition of study not
an irritant | Under the condition of study
not an irritant | Pass |
|----|-------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------|
| 4. | Acute Systemic Toxicity | Under the conditions of the
study, the device extracts do not
pose a systemic toxicity concern. | Under the conditions of the
study, the device extracts do
not pose a systemic toxicity
concern | Pass |
C. Clinical Test Data
Clinical study was not conducted as clinical data is not needed for O'Star Nitrile Examination Gloves Powder Free.
VIII. CONCLUSION
The conclusion drawn from the non-clinical tests demonstrate that the subject device, O'star Nitrile Examination Glove Powder Free are as safe, as effective and perform as well as or better than legally marketed predicate device in K210276.