(162 days)
K/DEN Number Not Found
No
The 510(k) summary describes a physical medical device (examination gloves) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device, disposable nitrile examination gloves, is intended to prevent contamination between patient and examiner, not to provide therapy or treatment for an illness or condition.
No
The device, disposable nitrile examination gloves, is intended to prevent contamination between patient and examiner and does not perform any diagnostic function.
No
The device is a physical product (gloves) and the description focuses on material properties and physical testing, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to prevent contamination between patient and examiner by being worn on the hand or finger. This is a barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description is of a physical glove, not a reagent, instrument, or system used to examine specimens from the human body.
- 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 those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on the physical properties and biocompatibility of the glove (watertightness, dimensions, physical properties, toxicity, sensitization, irritation), which are relevant to a barrier device, not a diagnostic test.
The device is clearly described as a medical device intended for a barrier function, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Disposable Nitrile Examination Gloves is a non-sterile 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
LZA
Device Description
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
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 acceptance criteria for each test.
Tests performed include:
- In Vitro Cytotoxicity Test: Agar diffusion Method. Result: Under the conditions of this study, the test article was Slight cytotoxic and was accepted in the agar diffusion method.
- Skin Sensitization Test: Guinea Pig Maximization. Result: The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
- Skin Irritation Test: Extraction Method. Result: The test result showed that the response of the test article extract was categorized as negligible under the test condition.
- Acute Systemic Toxicity Test: Extraction Method. Result: The test article showed no evidence of causing acute system toxicity in the ICR mice.
- Watertightness Test for Detection of Holes: Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (ISO 2859-1:1999), Standard Specification for Nitrile Examination Gloves for Medical Application (ASTM D6319 - 19), Standard Test Method for Detection of Holes in Medical Gloves (ASTM D 5151-19). Sample Demand: 125. Results: Number of Conforming: 125 Glove, Number of Non-confirming: 0 Glove.
- Physical Dimensions Test: Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (ISO 2859-1:1999), Standard Specification for Nitrile Examination Gloves for Medical Application (ASTM D6319 - 19), Standard Practice for Rubber—Measurement of Dimensions (ASTM D 3767-03(2014)). Sample Demand: 13. Result: The test result was considered to be acceptable.
- Determination of Physical Properties: Sampling procedures for inspection by attributes Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection (ISO 2859-1:1999), Standard Specification for Nitrile Examination Gloves for Medical Application (ASTM D6319 - 19), Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension (ASTM D 412-06a(2013)), Surface Powder Test of "powder-free" gloves: Standard Specification for Nitrile Examination Gloves for Medical Application (ASTM D6319 - 19), Standard Test Method for Rubber—Deterioration in an Air Oven (ASTM D 573-04(2015)), Medical gloves - Determination of removable surface powder ISO 21171-2006, Standard Test Method for Residual Powder on Medical Gloves ASTM D6124 - 06(2017). Result: The test result was considered to be acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
September 21, 2021
Foshan Kangkang Biotechnology Co., LTD Yico Xie General Manager 2nd Floor, Building 4, Dongfang Industrial Park, Xiaotang Industrial Avenue, Shishan Town, Nanhai District Foshan City, Guangdong 528225 China
Re: K211073
Trade/Device Name: Disposable Nitrile Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: August 4, 2021 Received: August 4, 2021
Dear Yico Xie:
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, PhD 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) K211073
Device Name
Disposable Nitrile Examination Gloves
Indications for Use (Describe)
Disposable Nitrile Examination Gloves is a non-sterile 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)
× Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K211073
Date of Summary Preparation: March 31, 2021 Date of Modification: July 23, 2021
1. Submitter's Identifications
Submitter's Name: FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD Address: 2nd Floor,Building 4,Dongfang Industrial Park, Xiaotang Industrial Avenue, Shishan Town, Nanhai District, Foshan City, Guangdong Province, China Contact Person: Yico Xie Contact Title: General Manager Contact E-mail Address: kangkang biotechnology(@aliyun.com Zip code: 528225 Telephone: +86-13702554142
2. Correspondent's Identifications
Correspondent's Name: FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD Address: 2nd Floor, Building 4, Dongfang Industrial Park, Xiaotang Industrial Avenue, Shishan Town, Nanhai District, Foshan City, Guangdong Province, China ZIP Code: 528225 Contact Person: Yico Xie Contact Title: General Manager Contact E-mail Address: Kangkangfda@126.com Telephone: +86-13702554142
3. Name of the Device
Device Classification Name: Non-powdered Patient examination glove Common Name: Polymer Patient Examination Glove Trade Name: Disposable Nitrile Examination Gloves Model/Size: S, M, L, XL Classification Panel: General Hospital Product Code: LZA Device Classification: Class I
4. The Predicate Devices
Powder Free Nitrile Patient Examination Gloves, Blue Color K181106
5. Device Description
The proposed device is Powder Free Nitrile Examination Gloves. The proposed device is blue. The proposed device is non-sterile.
6. Indications for Use
Disposable Nitrile Examination Gloves is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
4
7. Summary of Technological Characteristics
| Proposed Device | Primary predicate device | Comparison | |||
|---|---|---|---|---|---|
| 510k Number | K211073 | K181106 | |||
| Manufacturer | FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD | JiangSu DongXin Medical Technology Co., Ltd | |||
| Proprietary | |||||
| Name | Disposable Nitrile Examination Gloves | Powder Free Nitrile Patient Examination Gloves, Blue Color | |||
| Regulation | |||||
| Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same | ||
| Product Code | LZA | LZA | Same | ||
| Color | Blue | Blue | Same | ||
| Size | S, M, L, XL | S, M, L, XL | Same | ||
| Indications for | |||||
| Use | Disposable Nitrile Examination Gloves is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. | Powder Free Nitrile Patient Examination Gloves, Blue Color 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. | Same | ||
| Device | |||||
| Description and | |||||
| Specifications | Meets ASTM D6319-19 | Meets ASTM D6319-10 | Same | ||
| Freedom from | |||||
| Pinholes | |||||
| IL I AQL2.5 | 1) Inspection 125pcs, Inspection Level I AQL2.5, and Accept/Reject criteria of 7/8 |
- Water leakage test: 0 noncompliance. | | 1) Inspection Level I AQL2.5, and Accept/Reject criteria of 10/11
- Water leakage test: 5 noncompliance is allowed. | Similar | |
| Dimensions
-Length
ILS-2 AQL4.0 | Meets ASTM D6319-19
230mm min. for all sizes | | 232 mm min for all sizes | Similar | |
| Dimensions
-Width
IL S-2 AQL4.0 | Meets ASTM D6319-19
S 82-85mm
M 93-97mm
L 100-103mm
XL 110-111mm | | S 76-90mm
M 89-102mm
L 108-119mm
XL 115-128mm | Similar | |
| Dimensions
-Thickness
IL S-2 AQL4.0 | Meets ASTM D6319-19
Thickness (mm) min.
Finger: 0.13 | | Thickness (mm) min.
Finger: 0.08
Palm: 0.08 | Similar | |
| | Palm: 0.07 | | | | |
| Physical
Properties
IL S-2 AQL4.0 | Before Aging | After Aging | Before Aging | After Aging | Similar |
| Tensile Strength
(MPa) | 15.3-23.4 | 14.1-30.6 | 18-25 | 17-22 | Similar |
| Ultimate
Elongation (%) | 500.972-
595.086 | 416.106-
601.187 | 550-600 | 450-570 | |
| Residual Powder | 1) Checked on 5pcs
sub-samples (N=5). - Result as following: Mean:
0.18mg/glove | | 2) Checked on 5pcs
sub-samples (N=5). - Result as following: Mean:
0.1mg/pcs | | Similar |
| Materials | Nitrile | | Nitrile | | Same |
| Single Patient
Use | Single Patient Use | | Single Patient Use | | Same |
| Biocompatibility | Under the conditions of this
study, the test article was a
non irritant or non sensitizer | | Under the conditions of this
study, the test article was a
non irritant or non sensitizer | | Same |
| | Under the conditions of this
study, the test article was
slight cytotoxic to L-929 cells
and was accepted in the agar
diffusion method. | | Under the conditions of this
study, the test article was non
cytotoxicity to L-929 cells. | | Similar |
| | Under the conditions of this
study, the test article was
showed no evidence of causing | | Not publicly available | | Different7 |
| Labeling for the
legally marketed
device to which
substantial
equivalence is
claimed | -Powder Free
-Patient Examination Glove
-Single Use Only
- Manufactured For:
- Lot
-Blue color - Non sterile | | -Powder Free
-Patient Examination Glove
-Single Use Only - Manufactured For:
- Lot
-Blue color - Non sterile | | Same |
| Standard | ASTM D6319-19
ASTM D6124-06
(Reapproved 2017)
ASTM D5151-19
ISO 10993-5:2009
ISO 10993-10:2010
ISO 10993-11:2017 | | ASTM
D6319-10(Reapproved 2015)
ASTM D6124-06
(Reapproved 2017)
ASTM
D5151-06(Reapproved2015)
ISO 10993-5:2009
ISO 10993-10:2010 | | Similar8 |
Table 1 Comparison to Predicate Device
5
8. Summary of Non-Clinical Testing:
Non-clinical tests were conducted to verify that the proposed device met acceptance criteria
6
for each test.
ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
ISO10993-11:2017 Biological evaluation of medical devices - Part11: Tests for systemic toxicity, implemented test for acute system toxicity
ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
Summary of the non-clinical testing is shown as below:
7
FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| In Vitro Cytotoxicity Test: | |||
| Agar diffusion Method | The purpose of the test is to | ||
| determine the potential cytotoxicity | |||
| toxicity of a mammalian cell culture | |||
| (mouse fibroblast L-929 cells) in | |||
| response to the test article. | The test sample met the requirements of the test if the biological | ||
| response was less than or equal to grade 2. | Under the conditions of | ||
| this study, the test article | |||
| was Slight cytotoxic and | |||
| was accepted in the agar | |||
| diffusion method. | |||
| Skin Sensitization Test: | |||
| Guinea Pig Maximization | The test was designed to evaluate | ||
| the potential of a test article to cause | |||
| skin sensitization. The test is used as | |||
| a procedure for screening of contact | |||
| allergens in guinea pigs and | |||
| extrapolating the results to humans, | |||
| but it does not establish the actual | |||
| risk of sensitization. | Magnusson and Kligman grades of 1 or greater in the test group | ||
| generally indicate sensitization, provided grades of less than 1 | |||
| are seen in control animals. | |||
| If grades of 1 or greater are noted in control animals, then the | |||
| reactions of test animals which exceed the most severe reaction | |||
| in control animals are presumed to be due to sensitization. | |||
| If the response is equivocal, rechallenge is recommended to | |||
| confirm the results from the first challenge. | |||
| The outcome of the test is presented as the frequency of positive | |||
| challenge results in test and control animals. | The test article showed no | ||
| evidence | |||
| of | |||
| causing | |||
| delayed dermal | |||
| contact | |||
| sensitization in the guinea | |||
| pig. | |||
| Skin Irritation Test: | |||
| Extraction Method | To evaluate the potential | ||
| skin | |||
| irritation caused by test article | |||
| contact with the skin surface of | |||
| rabbits and extrapolating the results | |||
| to humans, but it does not establish | |||
| the actual risk of irritation. | When blank or negative control was used, calculate the primary | ||
| irritation score for the controls and subtract that score from the | |||
| score using the test material to obtain the primary irritation | |||
| score. | The test result showed that | ||
| the response of the test | |||
| article | |||
| extract | |||
| was | |||
| categorized as negligible | |||
| under the test condition. | |||
| Acute Systemic Toxicity Test: | |||
| Extraction Method | The test was designed to evaluate | ||
| the potential acute system toxicity | |||
| caused by test article contact with | |||
| the ICR mice and extrapolating the | |||
| results to humans. | Within the monitoring period (72 h), if the toxicosis response | ||
| of testing group is not greater than that of control group, the | |||
| testing sample is regarded as acceptable. In case that two or | |||
| more mice show the medium toxicosis symptom or die, the | |||
| testing sample is regarded as unacceptable. If any animals | |||
| treated with the sample show only slight signs of biological | |||
| reactivity, and not more than one animal shows gross symptoms | |||
| of biological reactivity or dies, repeat the testing using groups | |||
| of 10 animals. On the repeat test, if all 10 animals treated with | |||
| the sample show no scientifically meaningful biological | |||
| reactivity above the vehicle control animals during the | |||
| observation period, the sample meets the requirements of this | |||
| test. | The test article showed no | ||
| evidence of causing acute | |||
| system toxicity in the ICR | |||
| mice. |
8
| Watertightness Test for
Detection of Holes:
Sampling procedures for
inspection by attributes Part 1:
Sampling schemes indexed by
acceptance quality limit (AQL)
for lot-by-lot inspection (ISO
2859-1:1999)
Standard Specification for
Nitrile Examination Gloves for
Medical Application (ASTM
D6319 - 19)
Standard Test Method for
Detection of Holes in Medical
Gloves (ASTM D 5151-19) | The test was designed to validate the
properties of the test glove.
Water tightness test for detection of
holes, physical dimensions and
physical properties were performed
on the test glove to test its
properties.
The results showed each property of
the test glove was acceptable under
this test condition. | Items: Water lack,
Batch size: 35000
Inspectional level: I
AQL: 2.5
Sample Demand: 125
Criterion: ≤7 | Number of Conforming:
125 Glove
Number of Non-
confirming: 0 Glove | | | | | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--------------------------------------------------------|
| Physical Dimensions Test:
Sampling procedures for
inspection by attributes Part 1:
Sampling schemes indexed by
acceptance quality limit (AQL)
for lot-by-lot inspection (ISO
2859-1:1999)
Standard Specification for
Nitrile Examination Gloves for
Medical Application (ASTM
D6319 - 19)
Standard Practice for Rubber—
Measurement of Dimensions
(ASTM D 3767-03(2014)) | | Items: Physical dimension test
Batch size: 35000
Inspectional Level: S-2
AQL: 4.0
Sample Demand: 13 | The test result was
considered to be
acceptable. | | | | | | | | | | | | | | |
| Determination of Physical
Properties:
Sampling procedures for
inspection by attributes Part 1:
Sampling schemes indexed by
acceptance quality limit (AQL) | | Items Before Aging After Accelerated
Aging Tensile
Strength Ultimate
Elongation Tensile
Strength Ultimate
Elongation Physical
Requirements ≥14MPa ≥500% ≥14MPa ≥400% | | | | | | | | | | | | | | | The test result was
considered to be
acceptable. |
9
FOSHAN KANGKANG BIOTECHNOLOGY CO., LTD
| for lot-by-lot inspection (ISO 2859-1:1999)
Standard Specification for
Nitrile Examination Gloves for
Medical Application (ASTM D6319 - 19)
Standard Test Methods for
Vulcanized Rubber and
Thermoplastic Elastomers—
Tension (ASTM D 412-06a(2013))
Surface Powder Test of
"powder-free" gloves:
Standard Specification for
Nitrile Examination Gloves for
Medical Application (ASTM D6319 - 19)
Standard Test Method for
Rubber—Deterioration in an Air
Oven (ASTM D 573-04(2015))
Medical gloves - Determination
of removable surface powder
ISO 21171-2006
Standard Test Method for
Residual Powder on Medical
Gloves ASTM D6124 -
| 06(2017) | Inspection Level | S-2 | |||
|---|---|---|---|---|---|
| AQL | 4.0 | ||||
| Sample Size Code Letter | E | ||||
| Batch Size | 35000 | ||||
| Sample Demand | 13 | ||||
| Number of Non-conforming | ≤1 | ≤1 | ≤1 | ≤1 | |
| Powder-free Synthetic Exam | |||||
| 3 sets of 2 gloves/batch, Average: 0.63mg/glove | Analyte: Residual Powder | ||||
| Result: 0.18mg/glove | |||||
| The results showed each property of the test glove was acceptable under this test condition. |
10
9. Clinical Test Conclusion
Clinical testing is not needed for this device.
10. 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 predicated device.