(18 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier function of latex gloves, with no mention of AI or ML.
No
The primary function of the device, as stated in the 'Intended Use / Indications for Use' and 'Device Description', is to prevent contamination between the patient and examiner, not to treat or cure a disease or condition.
No
Explanation: The device, examination gloves, is intended to prevent contamination between patient and examiner, and is not used to diagnose any medical condition.
No
The device is a physical product (gloves made of natural rubber latex) and the description focuses on material properties and physical testing, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gloves are for preventing contamination between patient and examiner by being worn on the hand or finger. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description focuses on the physical properties and barrier function of the gloves. It mentions testing related to these properties (water leak, physical properties, etc.) and biocompatibility, which are typical for medical devices that come into contact with the body, but not for IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Single-use medical latex examination gloves 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)
LYY
Device Description
The proposed device. The Single-use medical latex examination qloves 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.
The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal 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 provided non-sterile, in sizes XS, S, M, L and XL, natural white color, powder free, and the shelf life is 3 years.
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 (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 tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- . ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- . ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- . ASTM D3578-19 Standard Specification for Rubber Examination Gloves
- . ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
- . ASTM D7160-05 Standard Practice for Determination of Expiration Dating for medical Gloves
- ISO 10993-1: 2009 Biological evaluation of medical devices Part1: Evaluation and .
- 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 5: Tests For systemic toxicity
Results:
- Physical Dimension (ASTM D3578-19): Meet the requirement
- Determination of Physical Properties (ASTM D3578-19): Meet the requirement
- Water Leak Test for Detection of Holes (ASTM D5151-19): Meet the requirement
- Residual Powder Content Test (ASTM D6124-06(2017)): Meet the requirement
- Protein Content (ASTM D3578-19): Meet the requirement
- In vitro Cytotoxicity (ISO 10993-5:2009): Failed Potential toxicity Grade (3 or 4)
- Skin Sensitization (ISO 10993-10:2010): Meet the requirement
- Skin irritation (ISO 10993-10:2010): Meet the requirement
- Systemic toxicity (ISO 10993-11:2017): Meet the requirement
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). 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 24, 2022
Fitone Latex Products Co., Ltd. Guangdong % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room1308,Baohua International Plaza,West Guangzhong Road 555 Jingan District Shanghai. 200072 China
Re: K222693
Trade/Device Name: Single-use medical latex examination gloves (LG100) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: August 30, 2022 Received: September 6, 2022
Dear Stuart Situ:
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. 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
Submission Number (if known)
Device Name
Single-use medical latex examination gloves (LG100)
Indications for Use (Describe)
The Single-use medical latex examination gloves 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)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary - K222693
I. Submitter
Fitone Latex Products Co., Ltd. Guangdong No.5 Huitong road, Lingbei Industrial Zone, Suixi, 524338 Zhanjiang, Guangdong, China
Contact person: Christine Ou Position: Manager Tel.: 0759-7905808 E-mail: market-intl@fitonelatex.com Preparation
date: September 20, 2022
Submission Correspondent
Ms. Stuart Situ Landlink Healthcare Technology (Shanghai) Co., Ltd. E-mail: stuart.situ@landlink-healthcare.com
US Agent
Qihui Zhang ZYPPEL LLC 1337 Massachusetts Avenue #158 Arlington MA, MA US 02476
II. Proposed Device
| Device Trade Name: | Single-use medical latex examination gloves |
|---|---|
| Model: | LG100 |
| Common name: | Latex Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LYY |
| Review Panel: | General Hospital |
III. Predicate Devices
| 510(k) Number: | K214017 |
|---|---|
| Trade name: | Examination gloves-Type A (Latex gloves) |
| Common name: | Latex Patient Examination Glove |
4
| Classification: | Class I |
|---|---|
| Product Code: | LYY |
| Manufacturer | Jiangxi Kemei Medical Apparatus & Instruments Group |
| Co., Ltd. |
IV. Device description
The proposed device. The Single-use medical latex examination qloves 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.
The proposed device is made of natural rubber latex and meet all the current specifications listed under the ASTM Specification D3578-19, Standard Specification for Rubber Examination Gloves. The principal 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 provided non-sterile, in sizes XS, S, M, L and XL, natural white color, powder free, and the shelf life is 3 years.
V. Indication for use
The Single-use medical latex examination gloves 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.
| Item | Proposed device
(K222693) | Predicate device
(K214017) | Discussion |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product
name | Single-use medical latex
examination gloves | Examination gloves-Type
A(Latex gloves) | - |
| Indications
For Use | The Single-use medical
latex examination gloves 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. | The Examination gloves-
Type A (Latex gloves) 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 |
| Product
Code | LYY | LYY | Same |
VI. Comparison of technological characteristics with the predicate devices Table 1 General Comparison of Single-use medical latex examination gloves
5
| Regulation No. | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
|---|---|---|---|
| Class | I | I | Same |
| Powdered or | |||
| Powdered free | Powdered free | Powdered free | Same |
| Material | Natural Rubber Latex | Natural Rubber Latex | Same |
| Color | No colour pigment added. | ||
| Natural White | No colour pigment added. | ||
| Natural White | Same | ||
| Dimensions | Length: | ||
| 6(XS): 238-241 mm | |||
| 61/2(S):240-245mm | |||
| 71/2(M): 240-245mm | |||
| 81/2(L):246-250mm | |||
| 9(XL): 246-252mm | Length: | ||
| S: 240-244mm | |||
| M: 241-245mm | |||
| L: 242-245mm | Similar | ||
| Meeting | |||
| requirem | |||
| ent of | |||
| ASTM D | |||
| 3578 | |||
| Width: | |||
| 6(XS): 74-76 mm | |||
| 61/2 (S):80-84mm | |||
| 71/2 (M): 94-97mm | |||
| 81/2 (L): 105-108mm | |||
| 9(XL): 114-120mm | Width: | ||
| S: 84-86mm | |||
| M: 96-98mm | |||
| L: 105-108mm | Similar | ||
| Meeting | |||
| requirem | |||
| ent of | |||
| ASTM D | |||
| 3578 | |||
| Palm Thickness: 0.11- | |||
| 0.13mm | |||
| Finger Thickness: 0.13- | |||
| 0.16mm | Palm Thickness: 0.11- | ||
| 0.13mm | |||
| Finger Thickness: 0.13- | |||
| 0.14mm | Similar | ||
| Meeting | |||
| requirem | |||
| ent of | |||
| ASTM D | |||
| 3578 | |||
| Biocompatibility | Non-sensitizing | ||
| Non-irritating | |||
| Non-systemic toxicity | Non-sensitizing | ||
| Non-irritating | |||
| Non-systemic toxicity | Same | ||
| Tensile | |||
| strength | Before Aging $24.4$ MPa, | ||
| min | |||
| Stress at | |||
| 500 % | |||
| Elongation | Before | ||
| Aging $20.6$ MPa, | |||
| min | |||
| Stress at | |||
| 500 % | |||
| Elongation | Similar | ||
| Meeting | |||
| requirem | |||
| ent of | |||
| ASTM D | |||
| $4.2$ Mpa, | |||
| max | $5.1$ Mpa, | ||
| max |
6
| After Aging | 20.5 MPa, min | After Aging | 18.9MPa, min | 3578 | |
|---|---|---|---|---|---|
| Ultimate Elongation | Before Aging | 650%, min | Before Aging | 683%, min | |
| After Aging | 524%, min | After Aging | 623%, min | ||
| Freedom from Holes | Meets ASTM D5151-19 AQL=2.5 | Meets ASTM D5151-19 AQL=2.5 | Same | ||
| Protein Content | Meets ASTM D5712-2015 | Meets ASTM D5712-2015 | Same | ||
| Powdered residue | Meets ASTM D6124-06(Reapproved 2017) | Meets ASTM D6124-06(Reapproved 2017) | Same | ||
| Sterility | Non-sterile | Non-sterile | Same | ||
| Shelf life | 3 Years | 5 Years | Similar¹ | ||
| Single Use | Yes | Yes | Same | ||
| Label and labeling | Meet FDA's Requirement | Meet FDA's Requirement | Same |
1 The Shelf life of proposed device and predicate device is different; However, the product performance after 3 years has been determined based on accelerated aging study. The results can demonstrate that the performance of proposed device meets the ASTM D3578 requirements after 3 years accelerated aging.
VII. Non-Clinical Testing
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- . ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- . ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves
- . ASTM D3578-19 Standard Specification for Rubber Examination Gloves
- . ASTM D5712-15 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
- . ASTM D7160-05 Standard Practice for Determination of Expiration Dating for medical Gloves
- ISO 10993-1: 2009 Biological evaluation of medical devices Part1: Evaluation and .
7
testing within a risk management process
- 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 5: Tests For systemic toxicity
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D3578-19 | Physical Dimension | The actual measured | |
| dimension of the | |||
| gloves shall be meet | |||
| the stated tolerance | |||
| specified in Table 2 of | |||
| the ASTM D3578-19 | |||
| Width ± 10mm | |||
| Length XS-S 220 min | |||
| and M-XL 230 min | |||
| Thickness (finger and | |||
| Palm): 0.08 min | Meet the | ||
| requirement | |||
| ASTM D3578-19 | Determination of | ||
| Physical Properties | Before and after | ||
| accelerated aging, the | |||
| gloves shall conform | |||
| to the physical | |||
| requirements in the | |||
| Table 3 of ASTM | |||
| D3578-19 | |||
| Before Aging: | |||
| Tensile Strength: 18 | |||
| MPa min | |||
| Stress Elongation: 5.5 | |||
| MPa max | |||
| Ultimate Elongation: | |||
| 650% min | |||
| After Accelerated | |||
| Aging: | |||
| Tensile Strength: 14 | |||
| MPa min | |||
| Ultimate Elongation: | |||
| 500% min | Meet the | ||
| requirement | |||
| ASTM D5151-19 | Water Leak Test for | ||
| Detection of Holes | The gloves shall be | ||
| free from hole when | |||
| tested in accordance | |||
| with the method given | |||
| in ASTM D5151 | |||
| AQL=2.5 | Meet the | ||
| requirement | |||
| ASTM D6124- | |||
| 06(2017) | Residual Powder | ||
| Content Test | The powder residue | ||
| content shall be not | |||
| more than 2mg per | |||
| glove. | Meet the | ||
| requirement | |||
| ASTM D3578-19 | Protein Content | $\leq$ 200 ug/dm² | Meet the |
| requirement | |||
| ISO 10993- | |||
| 5:2009 | In vitro Cytotoxicity | Non-cytotoxicity | Failed |
| Potential toxicity | |||
| Grade (3 or 4) | |||
| ISO 10993-10: | |||
| 2010 | Skin Sensitization | Non-sensitizing | Meet the |
| requirement | |||
| ISO 10993-10: | |||
| 2010 | Skin irritation | Non-irritating | Meet the |
| requirement | |||
| ISO 10993-11: | |||
| 2017 | Systemic toxicity | Non-systemic toxicity | Meet the |
| requirement |
8
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Single-use medical latex examination gloves is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K214017.