(118 days)
Not Found
No
The device is a sterile latex examination glove, a physical barrier device. The description focuses on material properties, physical performance, and sterilization, with no mention of software, algorithms, or data processing related to AI/ML.
No.
The device (gloves) is intended to prevent contamination between patient and examiner, not to provide therapy or treat a condition.
No
The device is described as an examination glove intended to prevent contamination between patient and examiner, not to diagnose a condition.
No
The device is a physical product (gloves) and does not involve any software components.
Based on the provided information, 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 physical barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The description focuses on the physical characteristics and performance of the glove as a barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on the physical properties, biocompatibility, and sterility of the glove, not on diagnostic accuracy or clinical outcomes related to a disease or condition.
IVD devices are specifically designed to perform tests on specimens from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Sterile Latex Examination Gloves Powder Free is a disposable device intended for medical purposes that is worn on the examiners' 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 Sterile Latex Examination Gloves Powder Free are natural color, single use only, disposable examination gloves intended for medical purposes to be worn by examination between the patient and the examiner. The device is ambidextrous and can be worn on either the left or right hand. The gloves are offered in sizes small, medium, large and extra-large, and sterilized by Gamma radiation.
The gloves are designed and manufactured in accordance with the ASTM D3578-19 standard.
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)
Summary of Non-Clinical Testing
A Biocompatibility
The following tests for the subject device were conducted the biocompatibility of Sterile Latex Examination Gloves Powder Free:
- ISO 10993-10: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- ISO 10993-11: Acute Systemic Toxicity
A Performance Testing
Physical performance testing of the proposed device was conducted as per ASTM D3578-19 Standard Specification for Rubber Examination Gloves.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D3578-19 Standard Specification for Rubber Examination Gloves
- 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
- 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
Test Results:
- Dimensions (width):
- Acceptance Criteria: Width 80±10 mm for Small size, 95±10 mm for Medium size, 105±10 mm for Large size, 115±10 mm for Extra large size. Length 230mm min. Palm – 0.08mm min. Finger-0.08mm min.
- Results: Pass. 81mm min for S, 95mm min for M, 106mm min for L, 115mm min for Extra L. 238mm min length. Palm – 0.11mm min. Finger—0.11mm min.
- Physical properties:
- Acceptance Criteria:
- Before Aging: Tensile Strength: 18 MPa, min. Elongation: 650%, min. Stress at 500% Elongation: 5.5MPa, max.
- After Aging: Tensile Strength: 14 MPa, min. Elongation: 500%, min.
- Results: Pass.
- Before Aging: Tensile Strength: 23.4MPa, min. Elongation: 650%, min. Stress at 500% Elongation: 5.3MPa, max.
- After Aging: Tensile Strength: 22MPa, min. Elongation: 704%, min.
- Acceptance Criteria:
- Freedom from holes:
- Acceptance Criteria: No leakage at sampling level of G-1, AQL 1.5
- Results: Pass. No leakage, 314 of 315 passed.
- Residual Powder:
- Acceptance Criteria:
§ 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 & Human Services and the Food and Drug Administration (FDA). The Department of Health & 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 22, 2023
Shandong Intco Medical Products Co. Ltd. % Ivv Wang Consultant Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai. 200122 China
Re: K223298
Trade/Device Name: Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LYY Dated: January 10, 2023 Received: January 12, 2023
Dear Ivy 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 (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 medical devices and radiation-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 -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
Indications for Use (Describe)
The Sterile Latex Examination Gloves Powder Free is a disposable device intended for medical purposes that is worn on the examiners' 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/3/Picture/0 description: The image shows the logo for INTCO Medical. The logo features the word "INTCO" in a bold, sans-serif font, with the letters in a dark blue color. Above the word "INTCO" is a stylized blue flower-like design with several petals radiating outward from a central point. Below the word "INTCO" are the Chinese characters for "Yingke Medical" in a lighter shade of gray.
510(K) Summary - K223298
(As requirement by 21 CFR 807.92)
Date prepared: 2023-02-22
A. Applicant: Name: Shandong Intco Medical Products Co., Ltd. Address: 9888 Qiwang Road, Naoshan Industrial Park, Qingzhou, Shandong, China Contact: Mr. John Zhao Title: Manager Tel: +86-536-6136888 Email: johnzhao@basicmedical.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) Common Name: Latex Patient Examination Gloves (Powder Free)
Regulatory Information Classification Name: Latex Patient Examination Glove Classification: Class I Product code: LYY Regulation Number: 21 CFR 880.6250 Review Panel: General Hospital
C. Predicate device:
K171367 SANCARE STERILE LATEX EXAMINATION GLOVES Sanrea Healthcare Products Pvt Ltd
D. Indications for use of the device:
The Sterile Latex Examination Gloves Powder Free is a disposable device intended for medical purposes that is worn on the examiners' hand or finger to prevent contamination between patient and examiner.
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E. Device Description:
The Sterile Latex Examination Gloves Powder Free are natural color, single use only, disposable examination gloves intended for medical purposes to be worn by examination between the patient and the examiner. The device is ambidextrous and can be worn on either the left or right hand. The gloves are offered in sizes small, medium, large and extra-large, and sterilized by Gamma radiation.
The gloves are designed and manufactured in accordance with the ASTM D3578-19 standard.
F. Summary of Technological Characteristics
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| 510K # | K223298 | K171367 | - |
| Product Name | Sterile Latex Examination Gloves Powder | ||
| Free | SANCARE STERILE LATEX | ||
| EXAMINATION GLOVES | - | ||
| Product Code | LYY | LYY | Same |
| Regulation | |||
| Number | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Indications for | |||
| use | The Sterile Latex Examination Gloves Powder | ||
| Free is a disposable device intended for | |||
| medical purposes that is worn on the | |||
| examiners' hand or finger to prevent | |||
| contamination between patient and | |||
| examiner. | The Sterile Latex Examination Gloves, | ||
| Powder Free, is a disposable device | |||
| intended for medical purposes that is | |||
| worn on the examiners' hand or finger | |||
| to prevent contamination between | |||
| patient and examiner. | Same | ||
| Powder free | Yes | Yes | Same |
| Design feature | Ambidextrous | Ambidextrous | Same |
| Material | Natural Rubber Latex | Natural Rubber Latex | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Gamma sterilized | Ethylene Oxide sterilized | Different |
| Use | Singe use | Single use | Same |
Table 1 General Comparison of Proposed and Predicate Devices
Analysis: The proposed device uses a different sterilization method than the predicate device. But both sterilization methods are current commonly used sterilization methods and the sterilization process validation has been conducted to demonstrate its effectiveness. Therefore, this difference does not raise any new safety or performance questions.
| Designation | Size | ||||||
|---|---|---|---|---|---|---|---|
| XS | S | M | L | XL | Tolerance | ||
| Predicate | |||||||
| device | |||||||
| (K171367) | Length, mm | 230 | 230 | 230 | 230 | 230 | min |
| Width, mm | 70 | 80 | 85 | 111 | 120 | $\pm$ 10 | |
| Thickness, mm | |||||||
| Finger | 0.08 | min | |||||
| Palm | 0.08 | min |
Table 2 Device dimension comparison
5
| Designation | Size | Tolerance | |||||
|---|---|---|---|---|---|---|---|
| Proposed | |||||||
| device | |||||||
| (K223298) | Length, mm | S | |||||
| 220 | M | ||||||
| 230 | L | ||||||
| 230 | XL | ||||||
| 230 | min | ||||||
| Width, mm | 80 | 95 | 111 | 120 | $\pm 10$ | ||
| Thickness, mm | |||||||
| Finger | 0.08 | min | |||||
| Palm | 0.08 | min | |||||
| Result | Similar |
Analysis: The physical dimensions are slightly different from that of the predicate, but they all meet the requirements of ASTM D3578-19, so the differences do not raise any new safety or performance questions.
Table 3 Performance comparison
| Item | | | Proposed device
(K223298) | Predicate device
(K171367) | Result |
|------------------------|-----------------|------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------|
| Color | | | Nature | Nature | Same |
| Physical
properties | Before
aging | Tensile strength | 18MPa, min | 18MPa, min | Same |
| | | Ultimate elongation | 650%, min | 650%, min | Same |
| | | Stress at 500%
Elongation | 5.5 MPa, Max | 5.5 MPa, Max | Same |
| | After
aging | Tensile strength | 14MPa, min | 14MPa, min | Same |
| | | Ultimate elongation | 500%, min | 500%, min | Same |
| | | Comply with ASTM D3578 | | Comply with ASTM
D3578 | Same |
| Freedom from holes | | | Be free from holes when
tested in accordance with
ASTM D3578 & ASTM
D5151
G-1, AQL 1.5 | Be free from holes when
tested in accordance
with ASTM D3578 &
ASTM D5151
G-1, AQL 2.5 | Different |
| Residual Powder | | | Meet the requirements
of ASTM D3578 & ASTM
D6124
Less than 2 mg per glove | Meet the requirements
of ASTM D3578 & ASTM
D6124
Less than 2 mg per glove | Same |
| Residual Protein | | | Meet the requirements
of ASTM D3578 & ASTM
D5712
Less than 200µg/dm² | Meet the requirements
of ASTM D3578 & ASTM
D5712
Less than 200µg/dm² | Same |
Analysis: The subject device tested the leakage performance with a different AQL as compared to the predicate device. A more stringent acceptance criterion does not affect the safety and performance of the proposed device.
Table 4 safety comparison
| Item | Proposed device | Predicate device | Result |
|---|---|---|---|
| ------ | ----------------- | ------------------ | -------- |
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| (K223298) | (K171367) | |||
|---|---|---|---|---|
| Material | Natural rubber latex | Natural rubber latex | Same | |
| Biocompatibility | Irritation | |||
| ISO 10993-10 | Under the | |||
| conditions of the | ||||
| study, not an | ||||
| irritant. Comply | ||||
| with ISO 10993-10. | Comply with ISO | |||
| 10993-10 | Same | |||
| Sensitization | ||||
| ISO 10993-10 | Under the | |||
| conditions of the | ||||
| study, not a | ||||
| sensitizer. Comply | ||||
| with ISO 10993-10. | ||||
| Acute systemic | ||||
| toxicity | ||||
| ISO 10993-11 | Under the / | |||
| conditions of the | ||||
| study, the device | ||||
| does not induce | ||||
| acute systemic | ||||
| toxicity response | Different |
Analysis: Toxicity information for the predicate device is not publicly available. This does not raise different safety or performance questions since the subject device has acceptable biocompatibility per the biocompatibility endpoint assessment.
G. Summary of Non-Clinical Testing
A Biocompatibility
The following tests for the subject device were conducted the biocompatibility of Sterile Latex Examination Gloves Powder Free:
- ISO 10993-10: Primary Skin Irritation
- ISO 10993-10: Dermal Sensitization
- ISO 10993-11: Acute Systemic Toxicity
A Performance Testing
Physical performance testing of the proposed device was conducted as per ASTM D3578-19 Standard Specification for Rubber Examination Gloves.
To summarize, the performance testing of the subject device was conducted to adequately demonstrate the effectiveness of the device in accordance with the relevant test methods cited below:
- ASTM D3578-19 Standard Specification for Rubber Examination Gloves
- 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
- 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
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Dimensions (width) | The purpose of the | Width $80\pm10$ mm for Small size | Pass |
| (thickness) | test is to evaluate | ||
| the physical | |||
| dimension of the | |||
| glove | $95\pm10$ mm for Medium size | ||
| $105\pm10$ mm for Large size | |||
| $115\pm10$ mm for Extra large | |||
| size | 81mm min for S | ||
| 95mm min for M | |||
| 106mm min for L | |||
| 115mm min for Extra L | |||
| Length 230mm min | 238mm min length | ||
| Palm – 0.08mm min. | |||
| Finger-0.08mm min. | Pass | ||
| Palm – 0.11mm min. | |||
| Finger—0.11mm min | |||
| Physical properties | The purpose of the | ||
| test is to evaluate | |||
| the tensile strength | |||
| and ultimate | |||
| elongation before | |||
| and after aging | Before Aging: | ||
| Tensile Strength: 18 MPa, min. | |||
| Elongation: 650%, min. | |||
| Stress at 500% Elongation: | |||
| 5.5MPa, max. | |||
| After Aging: | |||
| Tensile Strength: 14 MPa, min. | |||
| Elongation: 500%, min. | Pass | ||
| Before Aging: | |||
| Tensile Strength: 23.4MPa, min. | |||
| Elongation: 650%, min. | |||
| Stress at 500% Elongation: | |||
| 5.3MPa, max. | |||
| After Aging: | |||
| Tensile Strength: 22MPa, min. | |||
| Elongation: 704%, min. | |||
| Freedom from holes | The purpose of the | ||
| test is to detect | |||
| holes in the gloves | No leakage at sampling level of | ||
| G-1, AQL 1.5 | Pass | ||
| No leakage, 314 of 315 passed | |||
| Residual Powder | The purpose of the | ||
| test is to detect the | |||
| powder residue in | |||
| the glove |