(224 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of examination gloves, with no mention of AI or ML.
No.
Therapeutic devices are used to cure, mitigate, treat, or prevent a disease, whereas this device is a glove for preventing contamination.
No
Explanation: The device description states that the Powder Free Nitrile Gloves are intended for medical purposes as a barrier to prevent contamination between patient and examiner. There is no mention of the device being used to diagnose conditions or process any type of data for diagnostic purposes.
No
The device description clearly identifies the device as physical gloves made of nitrile, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
- Device Description and Intended Use: The description clearly states the device is a "Powder Free Nitrile Glove" intended to be "worn on the examiner's hands to prevent contamination between patient and examiner." This is a physical barrier device used on the body (or on the hands of the user interacting with the body), not for analyzing specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in samples.
- Providing diagnostic information about a disease or condition.
- Using reagents or analytical methods.
The device described is a Class I medical device (specifically, a patient examination glove) used for barrier protection.
N/A
Intended Use / Indications for Use
The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner. This device is a disposable product, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The Powder Free Nitrile Gloves are non-sterile disposable patient examination gloves. The gloves are blue and powder free. The Powder Free Nitrile Gloves come in four sizes: Small, Medium, Large, X Large. The Powder Free Nitrile Gloves act as a barrier to prevent contamination between patient and examiner. The device meets all requirements of ASTM D6319-19.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Examiner (medical purposes)
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: Powder Free Nitrile Gloves were evaluated for technological characteristics against ASTM or equivalent standards.
Key results:
- Dimension: Met ASTM D6319-19 standards for length, width, and thickness (finger and palm) for sizes Small, Medium, Large, and X Large.
- Physical Properties: Met ASTM D6319-19 standards for Tensile strength and Ultimate elongation both before and after aging.
- Freedom from pinholes: Passed ASTM D5151-19, with no water leakage and met Standard Acceptance Criteria, AQL=2.5.
- Powder Residual: Met ASTM D6319-19 and ASTM D6124-06 (Reapproved 2017) with 0.3mg/glove, which is
§ 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 6, 2022
St Future International Limited % Bing Huang Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road ShenZhen, GuangDong 518100 China
Re: K213448
Trade/Device Name: Powder Free Nitrile Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: April 28, 2022 Received: May 5, 2022
Dear Bing Huang:
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
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 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.
Bifeng Qian, M.D., 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213448
Device Name Powder Free Nitrile Gloves
Indications for Use (Describe)
The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
This device is a disposable product, provided non-sterile.
| 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
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
K213448
(1) Applicant information:
| 510(k) owner's name: | ST FUTURE INTERNATIONAL LIMITED |
|---|---|
| Address: | FLAT/RM 08 9/F CHEVALIER COMMERCIAL CENTRE 8 |
| WANG HOT ROAD KOWLOON BAY HK | |
| Contact person: | Ivan Tan |
| Phone number: | +86-13416165207 |
| Email: | qa01@st-future.com |
| Date of summary prepared: | 2022-6-2 |
(2) Proprietary name of the device
| Trade name/model: | Powder Free Nitrile Gloves |
|---|---|
| Common name: | Polymer Patient Examination Glove |
| Regulation number: | 21 CFR 880.6250 |
| Product code: | LZA |
| Review panel: | General Hospital |
| Regulation class: | Class I |
(3) Predicate device
| Predicate device | |
|---|---|
| Sponsor | Onetexx Sdn Bhd |
| Device Name and Model | Blue Nitrile Powder Free Patient Examination Glove, Non Sterile |
| 510(k) Number | K210366 |
| Product Code | LZA |
| Regulation Number | 21 CFR 880.6250 |
| Regulation Class | Class I |
(4) Description/ Design of device:
The Powder Free Nitrile Gloves are non-sterile disposable patient examination gloves. The gloves are blue and powder free. The Powder Free Nitrile Gloves come in four sizes: Small, Medium, Large, X Large.
The Powder Free Nitrile Gloves act as a barrier to prevent contamination between patient and
4
examiner. The device meets all requirements of ASTM D6319-19.
(5) Indications for use:
The Powder Free Nitrile Gloves is intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
This device is a disposable product, provided non-sterile.
(6) Materials
| Product name | Material of product | Color additives | Body contract category | Contact duration |
|---|---|---|---|---|
| Powder Free | ||||
| Nitrile Gloves | Nitrile | Blue | Surface and external | |
| communicating device | Less than 24 hours |
(7) Technological Characteristic Comparison Table
| Item | Subject device | Predicate device | Remark |
|---|---|---|---|
| Company | ST FUTURE | Onetexx Sdn Bhd | / |
| INTERNATIONAL | |||
| LIMITED | |||
| Trade name | Powder Free Nitrile Gloves | Blue Nitrile Powder Free | / |
| Patient Examination Glove, | |||
| Non Sterile | |||
| 510 (k) number | K213448 | K210366 | / |
| Regulation number | 21CFR 880.6250 | 21 CFR 880.6250 | Same |
| Product code | LZA | LZA | Same |
| Size | S/ M/ L/ XL | Extra Small/ Small/ Medium/ | Same |
| Large/ Extra Large | |||
| Class | I | I | Same |
| Indications for use/ | |||
| Intended use | The Powder Free Nitrile | ||
| Gloves is intended for | A patient examination glove | ||
| is a disposable device made | Similar, | ||
| only | |||
| wording | |||
| difference | |||
| medical purposes that is | of synthetic rubber latex | ||
| worn on the examiner's | intended for medical purposes | ||
| hands to prevent | that is worn on the examiner's | ||
| contamination between | hand or finger to prevent | ||
| patient and examiner. | contamination between | ||
| This device is a disposable | patient and examiner. | ||
| product, provided | |||
| non-sterile. | |||
5
ST FUTURE INTERNATIONAL LIMITED
510(k)s – Section 1. 510 (k) Summary
| Dimensions: | |||||
|---|---|---|---|---|---|
| S | Length | 246mm | 249mm | Different | |
| but within the ASTM D6319 | |||||
| Width | 86.4mm | 87.0mm | |||
| Thic | Finger | 0.11mm | 0.10mm | ||
| kness | Palm | 0.08mm | 0.07mm | ||
| M | Length | 243mm | 249mm | ||
| Width | 96.9mm | 98.0mm | |||
| Thic | Finger | 0.12mm | 0.10mm | ||
| kness | Palm | 0.09mm | 0.07mm | ||
| L | Length | 255mm | 248mm | ||
| Width | 106mm | 107mm | |||
| Thic | Finger | 0.12mm | 0.10mm | ||
| kness | Palm | 0.09mm | 0.07mm | ||
| X | |||||
| L | Length | 251mm | 250mm | ||
| Width | 116mm | 117mm | |||
| Thic | Finger | 0.12mm | 0.10mm | ||
| kness | Palm | 0.08mm | 0.07mm | ||
| Physical Properties: | |||||
| Different | |||||
| but within the ASTM D6319 | |||||
| Before Aging | |||||
| Tensile strength | 34.56MPa | 32.35MPa | |||
| Ultimate elongation | 556% | 568% | |||
| After Aging | |||||
| Tensile strength | 36.34MPa | 36.10MPa | |||
| Ultimate elongation | 485% | 551% | |||
| Freedom from | |||||
| Pinholes Holes | In accordance with ASTM | ||||
| D5151-19 | In accordance with ASTM | ||||
| D5151-19 | Same | ||||
| Inspection level: G-1 | |||||
| AQL=2.5 | Inspection level: G-1 | ||||
| AQL=2.5 | |||||
| Residual Powder | 0.3mg/glove | 0.24mg/glove | Different | ||
| but within the ASTM D6124 | |||||
| Materials used to | |||||
| fabricate the devices | Nitrile | Nitrile | Same | ||
| Color | Blue | Blue | Same |
6
| Compare
performance data
supporting
substantial
equivalence | Meets ASTM D5151-19
ASTM D6319-19
ASTM D6124-06
(Reapproved 2017) | Meets ASTM D5151-19
ASTM D6319-19
ASTM D6124-06
(Reapproved 2017) | Same | |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-----------|
| Single Use | Single Use | Single Use | Same | |
| Biocompatibility | Under the conditions of this
study, the test article extract
showed no significant
evidence of causing skin
sensitization in the guinea
pig. Complies with ISO
10993-10:2010. | The test material did not
produce a skin sensitization
effect in the guinea pigs.
Complies with ISO
10993-10:2010. | Same | |
| | The test result showed that
the irritant response of the
test article extract was
categorized as negligible
under the test condition.
Complies with ISO
10993-10:2010. | The test material did not
cause an irritant response.
The Primary Irritant
Response Category is deemed
'Negligible'. Complies with
ISO 10993-10:2010. | Same | |
| | According to ISO 10993-5:
2009, the test material
demonstrated a cytotoxic
effect under the condition of
this study. Additional test
i.e. Acute Systemic Toxicity
was tested. | According to ISO 10993-5:
2009, the test material
demonstrated a cytotoxic
effect under the condition of
this study. Additional test i.e.
Acute Systemic Toxicity was
tested. | Same | |
| | Under the conditions of this
study, there was no
evidence of systemic
toxicity from the extract.
Complies with ISO
10993-11:2017 | The test item did not induce
any systemic toxicity.
Complies with ISO 10993-
11:2017 | Same | |
| | Shelf-life | 3 years | Not known | Different |
Note 1: Although the shelf-life data of the predicate device are unknown, but the subject device has been validated to the shelf-life of 3 years, so the difference does not affect safety and effectiveness.
7
(8) Summary of Non-Clinical Testing:
Powder Free Nitrile Gloves are summarized with the following technological characteristics compared to ASTM or equivalent standard.
| Characteristics | Standard | Result | |
|---|---|---|---|
| Dimension | ASTM D6319-19 | ||
| Small | |||
| Length | $\geq220mm$ | 246mm | |
| Width | 80±10mm | 86.4mm | |
| Thickness Finger | $\geq0.05mm$ | 0.11mm | |
| Palm | $\geq0.05mm$ | 0.08mm | |
| Medium | |||
| Length | $\geq230mm$ | 243mm | |
| Width | 95±10mm | 96.9mm | |
| Thickness Finger | $\geq0.05mm$ | 0.12mm | |
| Palm | $\geq0.05mm$ | 0.09mm | |
| Large | |||
| Length | $\geq230mm$ | 255mm | |
| Width | 110±10mm | 106mm | |
| Thickness Finger | $\geq0.05mm$ | 0.12mm | |
| Palm | $\geq0.05mm$ | 0.09mm | |
| X large | |||
| Length | $\geq230mm$ | 251mm | |
| Width | 120±10mm | 116mm | |
| Thickness Finger | $\geq0.05mm$ | 0.12mm | |
| Palm | $\geq0.05mm$ | 0.08mm | |
| Physical Properties | ASTM D6319-19 | ||
| Before aging | Tensile strength $\geq14MPa$ | 34.56MPa | |
| Ultimate elongation $\geq500%$ | 556% | ||
| After aging | Tensile strength $\geq14MPa$ | 36.34MPa | |
| Ultimate elongation $\geq400%$ | 485% | ||
| Freedom from pinholes | ASTM D5151-19 | Pass, no water leakage | |
| Passed Standard Acceptance Criteria, AQL=2.5 | |||
| Powder Residual | ASTM D6319-19 and ASTM D6124-06 (Reapproved 2017) | Meets |