(199 days)
Not Found
No
The 510(k) summary describes a standard patient examination glove and makes no mention of AI or ML technology.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner, not to treat or diagnose a disease or condition.
No
The device, a patient examination glove, is intended to prevent contamination between patient and examiner. Its function does not involve diagnosing medical conditions, but rather providing a barrier.
No
The device is a physical glove, not software. The description clearly states it is a nitrile patient examination glove and details physical properties and testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "worn on the examiner's hands to prevent contamination between patient and examiner." This describes a barrier device used for infection control, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or screening.
- Device Description: The description details a nitrile patient examination glove, focusing on its material, physical properties, and compliance with a standard for examination gloves. This aligns with a medical device used for protection, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information. The performance studies focus on biocompatibility and physical integrity, which are relevant to a barrier device, not an IVD.
Therefore, this device falls under the category of a medical device, specifically a patient examination glove, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The proposed device is a nitrile patient examination glove. The design of proposed device addresses the standard specification requirements of ASTM D6319-19. The proposed device is non-sterile and powder free, with fern green, midnight black and sky blue three colors.
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
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)
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
Tests Performed:
- Tests For Skin Sensitization (ISO 10993-10:2021)
Results for Fern Green, Blue Sky, and Midnight Black gloves: No sensitization response observed. All passed. - Tests For Skin Irritation (ISO 10993-23:2021)
Results for Fern Green, Blue Sky, and Midnight Black gloves: No abnormality detected, classified as "non-irritant". All passed. - In Vitro Cytotoxicity (ISO 10993-5:2009)
Results for Fern Green, Blue Sky, and Midnight Black gloves: Cell viability was less than 70% at 25, 50, and 100% test item extracts, indicating potential cytotoxicity. All failed this specific test. - Systemic toxicity (ISO 10993-11:2017)
Results for Fern Green, Blue Sky, and Midnight Black gloves: No animal deaths or loss in body weight, did not reveal systemic toxicity. All passed. - Residual Powder on Medical Gloves (ASTM D6124-06 (2022))
Results: Fern Green: 0.6 mg/glove, Blue Sky: 0.9 mg/glove, Midnight Black: 0.8 mg/glove. All passed (limit: 2.0 mg/glove). - Detection of Holes in Medical Gloves (ASTM D5151-2006)
Results: Fern Green: 0 Glove leakage, Blue Sky: 0 Glove leakage, Midnight Black: 0 Glove leakage. All passed (AQL: 2.5). - Physical dimensions (ASTM D6319-19)
All colors and sizes (S, M, L, XL) met the specified length and width requirements. All passed. - Thickness (ASTM D3767-03 (2003))
All colors met the specified finger and palm thickness requirements (>= 0.05 mm). All passed. - Physical properties: Before aging (ASTM D412-16)
Tensile strength: All colors (Fern Green, Blue Sky, Midnight Black) had average tensile strengths > 14 MPa. All passed.
Ultimate Elongation: All colors had average ultimate elongation > 500%. All passed. - After Accelerated Aging Tensile strength
All colors had average tensile strengths > 14 MPa. All passed.
Ultimate Elongation: All colors had average ultimate elongation > 400%. All passed.
No clinical study is included in this submission.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
October 6, 2023
3A Glove Sdn. Bhd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K230777
Trade/Device Name: Patient Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 6, 2023 Received: September 7, 2023
Dear Boyle Wang:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Allan T
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control
2
and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230777
Device Name Patient Examination Gloves
Indications for Use (Describe)
The Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands 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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4
510(k) Summary K230777
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR 807.92.
1.0 submitter's information
Name: 3A Glove Sdn. Bhd. Address: PTD 2058 & 2059, Jalan Cyber 4, Kawasan Perindustrian Senai (III), 81400 Senai, Johor, Malaysia Phone Number: +60127708756 Contact: Poh Seng Ping Date of Preparation: 2023.09.26
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Patient Examination Gloves Common name: Patient Examination Gloves Classification name: Non-powdered patient examination glove Model(s): S. M. L. XL Colors: FERN GREEN/ MIDNIGHT BLACK/ SKY BLUE
3.0 Classification
Production code: LZA Regulation number: 21CFR880.6250 Classification: Class I Panel: General Hospital
4.0 Predicate device information
- Manufacturer: Ever Global (Vietnam) Enterprise Corp Device: Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color
5
510(k) number: K171422
5.0 Indications for use
The Patient Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
6.0 Device description
The proposed device is a nitrile patient examination glove. The design of proposed device addresses the standard specification requirements of ASTM D6319-19. The proposed device is non-sterile and powder free, with fern green, midnight black and sky blue three colors.
7.0 Summary comparing technological characteristics with predicate device
| Item | Proposed device | Predicate device | Remark |
|---|---|---|---|
| 510(k) number | K230777 | K171422 | Same |
| Product Code | LZA | LZA | Same |
| Regulation No. | 21CFR880.6250 | 21CFR880.6250 | Same |
| Class | I | I | Same |
| Indications for use | The Patient Examination | ||
| Gloves is a disposable | |||
| device intended for | |||
| medical purposes that is | |||
| worn on the examiner's | |||
| hands to prevent | |||
| contamination between | |||
| patient and examiner. | The Disposable Powder | ||
| Free Nitrile Examination | |||
| Glove, White/ Blue/ Black/ | |||
| Pink Color is a disposable | |||
| device intended for | |||
| medical purposes that is | |||
| worn on the examiner's | |||
| hands to prevent | |||
| contamination between | |||
| patient and examiner. | Same | ||
| Powdered or Powder free | Powder free | Powder free | Same |
| Design Feature | ambidextrous | ambidextrous | Same |
| Labeling Information | Single-use indication, | ||
| powder free, device color, | |||
| device name, glove size | |||
| and quantity, Patient | |||
| Examination Gloves, | |||
| Non-Sterile | Single-use indication, | ||
| powder free, device color, | |||
| device name, glove size | |||
| and quantity, Disposable | |||
| Powder Free Nitrile | |||
| Examination Glove, | |||
| Non-Sterile | Same |
Table1-General Comparison
6
| Predicate | Designation | Size | Tolerance | ||||
|---|---|---|---|---|---|---|---|
| Device(K171422) | Length, mm | XS | |||||
| 230 | S | ||||||
| 230 | M | ||||||
| 230 | L | ||||||
| 230 | XL | ||||||
| 230 | min | ||||||
| Width, mm | 75 | 85 | 95 | 105 | 115 | ±5 | |
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Proposed Device | Designation | Size | Tolerance | ||||
| Length, mm | S | ||||||
| 220 | M | ||||||
| 230 | L | ||||||
| 230 | XL | ||||||
| 230 | min | ||||||
| Width, mm | 80 | 95 | 110 | 120 | ±10 | ||
| Thickness, mm: | |||||||
| Finger | 0.05 | min | |||||
| Palm | 0.05 | min | |||||
| Remark | Analysis1 |
Table2 Device Dimensions Comparison
Analysis1: The sizes and tolerances of proposed device are different with those of the predicate, but they all meet the requirements of ASTM D6319-19.
| Item | Proposed device | Predicate device | Remark | ||
|---|---|---|---|---|---|
| Color | FERN GREEN/ MIDNIGHT | ||||
| BLACK/ SKY BLUE | White/ Blue/ Black/ Pink | Analysis 2 | |||
| Physical | |||||
| Properties | Before | ||||
| Aging | Tensile | ||||
| Strength | 14MPa, min | 14MPa, min | SAME | ||
| Ultimate | |||||
| Elongation | 500%min | 500%min | SAME | ||
| After | |||||
| Aging | Tensile | ||||
| Strength | 14MPa, min | 14MPa, min | SAME | ||
| Ultimate | |||||
| Elongation | 400%min | 400%min | SAME | ||
| Comply with ASTM D6319 | Comply with ASTM D6319 | SAME | |||
| Freedom from Holes | Be free from holes when | ||||
| tested in accordance with | |||||
| ASTMD5151 AQL=2.5 | Be free from holes when | ||||
| tested in accordance with | |||||
| ASTMD5151 AQL=2.5 | SAME | ||||
| Powder Content | Fern Green 0.6 mg/glove | ||||
| Midnight black 1.1 mg/glove | |||||
| Sky blue 1.0 mg/glove | Meet the requirements of | ||||
| ASTM D6124 | SIMILAR |
Table3 Performance Comparison
Analysis 2: The proposed device has different color to the predicate device, but all proposed devices are conducted the performance tests.
7
| Item | Proposed device | Predicate device | Remark | |
|---|---|---|---|---|
| Material | Nitrile | Nitrile | SAME | |
| Biocompatibility | Irritation | Under the conditions of the study, not an irritant | Comply with ISO10993-10 | SAME |
| Sensitization | Under conditions of the study, not a sensitizer. | |||
| Cytotoxicity | Under the conditions of the study, the device is potentially cytotoxic | Comply with ISO10993-5 | Analysis 3 | |
| Systemic toxicity | Under the conditions of the study, the device does not elicit an acute systemic toxicity response. | Complies with ISO 10993-11 Third edition 2017-09 | ||
| Label and Labeling | Meet FDA's Requirement | Meet FDA's Requirement | SAME |
Table4 Safety Comparison
Analysis 3: The proposed device is potentially cytotoxic, but all proposed devices passed the acute systemic toxicity test.
8.0 Summary of Non-Clinical Performance Testing
The following performance data has been provided to demonstrate that the subject device meets the acceptance criteria in the standard.
Table 5 Summary of Non-Clinical Performance Testing
| No. | Name of the
Test
Methodology | Standard | Acceptance
Criteria | Results | Pass
/ Fail |
|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------|----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| 1 | Tests For Skin
Sensitization | ISO
10993-10:2
021. | Skin
Sensitization
Test:
provided
grades less
than 1,
otherwise
sensitization. | Fern Green:
No sensitization response was observed in control and treatment group animals.
Based on results of the study, it is inferred that the polar and non-polar extracts of the test item “Powder Free Nitrile Examination Gloves Color: Fern Green” is classified as “non-sensitizer” and has met the skin sensitization test requirement of ISO 10993-10:2021. | Pass |
| | | | | Blue Sky:
No sensitization response was observed in control | Pass |
| | | | | | |
| | | | | and treatment group animals. | |
| | | | | Based on results of the study, it is inferred that the | |
| | | | | polar and non-polar extracts of the test item | |
| | | | | "Powder Free Nitrile Examination Gloves
Color: Blue Sky" is classified as "non-sensitizer" and | |
| | | | | has met the skin sensitization test requirement of
ISO 10993-10:2021. | |
| | | | | Midnight Black: | Pass |
| | | | | No sensitization response was observed in control
and treatment group animals. | |
| | | | | Based on results of the study, it is inferred that the
polar and non-polar extracts of the test item | |
| | | | | "Powder Free Nitrile Examination Gloves
Color: Midnight Black" is classified as
"non-sensitizer" and has met the skin sensitization
test requirement of ISO 10993-10:2021. | |
| | | | | | |
| 2 | Tests For skin
Irritation | ISO
10993-23:2
021. | Skin Irritation
Test:
If the primary
irritation
index
is
0-0,4, the
response
category is
Negligible.
0,5-1,9
means slight
2-4,9 means
moderate
5-8 means
severe | Fern Green:
At necropsy, there was no abnormality detected in
any of the animals.
the test item "POWDER FREE NITRILE
EXAMINATION GLOVES COLOR: FERN GREEN"
is "non-irritant" to the New Zealand white rabbits
and has met the skin irritation test requirement of
ISO 10993-23:2021. | Pass |
| | | | | | |
| | | | | Blue Sky: | Pass |
| | | | | At necropsy, there was no abnormality detected in
any of the animals.
Based on results of the study, it is inferred that the
polar and non-polar extracts of the test item
"POWDER FREE NITRILE EXAMINATION
GLOVES COLOR: Blue Sky" is "non-irritant" to the
New Zealand white rabbits and has met the skin
irritation test requirement of ISO 10993-23:2021. | |
| | | | | | |
| | | | | Midnight Black:
At necropsy, there was no abnormality detected in
any of the animals.
Based on results of the study, it is inferred that the
polar and non-polar extracts of the test item
"POWDER FREE NITRILE EXAMINATION
GLOVES COLOR: Midnight Black" is "non-irritant" | Pass |
| to the New Zealand white rabbits and has met the
skin irritation test requirement of ISO
10993-23:2021. | | | | | |
| 3 | In Vitro
Cytotoxicity | ISO
10993-5:2009 | The viab.%
of the 100%
extract of the
test article is
the final
result, and if
viability is
reduced to
14MPa | Fern Green: | Pass | |
8
9
10
11
12
| strength | Average Tensile strength: 17.23 MPa | ||
|---|---|---|---|
| Blue Sky: | |||
| Average Tensile strength: 17.17 MPa | |||
| Midnight Black: | |||
| Average Tensile strength: 17.25 MPa | |||
| Ultimate | |||
| Elongation | ≥500% | Fern Green: | |
| Average Ultimate Elongation: 540% | Pass | ||
| Blue Sky: | |||
| Average Ultimate Elongation: 539% | |||
| Midnight Black: | |||
| Average Ultimate Elongation: 541% | |||
| After | |||
| Accelerated | |||
| Aging | |||
| Tensile | |||
| strength | ≥14MPa | Fern Green: | |
| Average Tensile strength: 16.30 MPa | Pass | ||
| Blue Sky: | |||
| Average Tensile strength: 16.32 MPa | |||
| Midnight Black: | |||
| Average Tensile strength: 16.23 MPa | |||
| Ultimate | |||
| Elongation | ≥400% | Fern Green: | |
| Average Ultimate Elongation: 450% | Pass | ||
| Blue Sky: | |||
| Average Ultimate Elongation: 449% | |||
| Midnight Black: | |||
| Average Ultimate Elongation: 452% |
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
10.0 Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K171422.