The powder free nitrile surgical glove, white color (Brand Name: Titanfine), is a sterile and single use device made of synthetic rubber intended to be worn by operation room personnel to protect a surgical wound from contamination. The gloves do not contain lubricating or dusting powder.

Device Description

Surgical glove is a disposable device worn on the surgical room personnel's hand or finger to prevent contamination during surgical procedures. The principle of operation is to provide a physical barrier between the surgical personnel's hands and the patient's open wound.

The powder free nitrile surgical gloves described in this submission are made of synthetic nitrile rubber, and are sterile that meets all of the requirements of ASTM standard D 3577-2009. They have white color and are single use.

The powder free nitrile surgical gloves described in this submission are tested for dimension, percent elongation, tensile, tensile at 500% elongation, free of pinholes, residue powder, water soluble proteins. The test results conform to related requirements in ASTM 3577-2009.

The powder free nitrile surgical gloves described in this submission are also tested biocompatibility per ISO 10993-10. The test results conform to related requirements in the standard.

The product sterilization is performed using radiation and the procedure is validated per ISO 11137-2: 2006.

AI/ML Overview

This document is a 510(k) premarket notification for Powder Free Sterile Nitrile Surgical Gloves, White Color (Brand Name: Titanfine). It does not describe a study involving an AI device and human readers, but rather the substantial equivalence of a medical device (surgical gloves) to a predicate device. Therefore, many of the requested categories related to AI performance, human expert evaluation, and training/test sets are not applicable.

However, I can extract the acceptance criteria and demonstrated performance for the surgical gloves based on the provided text.

Here's a summary of the requested information, adapted for this medical device submission:

1. A table of acceptance criteria and the reported device performance

Description	Acceptance Criteria (Predicate Device K122557)	Reported Device Performance (Subject Device K140989)
Dimension
Length	≥265 mm	≥265 mm
Width	within ±6 mm of specified value in ASTM 3577:2009	within ±6 mm of the specified value in ASTM 3577:2009
Palm, Finger, Cuff Thickness	≥0.10 mm	≥0.10 mm
Tensile Strength (MPa)	≥17	≥17
Tensile at 500% Elongation (MPa)	≤ 7.0	≤ 7.0
Percent Elongation	≥650	≥650
Free of Pinhole	Free of pinholes at AQL = 1.5	Free of pinholes at AQL = 1.5
Residue Powder	≤ 2.0 mg	≤ 2.0 mg
Water Soluble Protein	≤ 200 µg/dm²	≤ 200 µg/dm²
Primary Skin Irritation (ISO 10993-10: 2010)	Not a primary skin irritant	Not a primary skin irritant (Grade <1.0) under the conditions of study
Dermal Sensitization (ISO 10993-10: 2010)	Not a dermal sensitizer	Not a dermal sensitizer (Grade 0 or 1) under the conditions of study

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes for each test. It states: "The test results conform to related requirements in ASTM 3577-2009." and "Tests were conducted following the recommended procedures outlined in the respective consensus standards." These standards typically define the sampling plans. The manufacturer is Hebei HongSen Plastics Technology Co., Ltd in Hebei Province, China, implying the testing likely occurred in China or by a contracted lab. The study is prospective in the sense that the device was manufactured and then tested to show compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a submission for sterile surgical gloves, not an AI diagnostic device requiring expert interpretation for ground truth. Compliance is determined by physical and chemical testing against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Compliance for surgical gloves is determined by objective measurement against pre-defined ASTM and ISO standards, not by human adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the surgical gloves, the "ground truth" or reference standards are the consensus standards themselves, specifically:

ASTM D3577-09 (Standard Specification for Rubber Surgical Gloves)
ASTM D6124-06 (Standard Test Method for Residual Powder on Medical Gloves)
ASTM D5151-06 (Standard Test Method for Detection of Holes in Medical Gloves)
ASTM D5712-10 (Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Isoprene Rubber Condoms)
ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
ISO 11137-2: 2006 (Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose)

8. The sample size for the training set

Not applicable. This is not an AI device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure, with three profiles overlapping to create a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the figure in a circular pattern.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 22, 2014

Hebei Hongsen Plastics Technology Co., Ltd. C/O Mr. Charles Shen Manager Manton Business and Technology Services 853 Dorchester LN, Unit-B New Milford, NJ 07646

Re: K140989

Trade/Device Name: Powder Free Sterile Nitrile Surgical Gloves; White Color (Brand Name: Titanfine) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 23, 2014 Received: November 26, 2014

Dear Mr. Shen:

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. 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.

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Page 2 - Mr. Shen

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Teiashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K140989

Device Name

Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine)

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Hebei HongSen Plastics Technology Co., Ltd 15 Eastern Industrial Accumulation Area, Nangong Town, Xingtai City, Hebei Province, China Tel: (086) 311-85656588

Section 5: 510(k) Summary: K140989

This summary of 510k is being submitted in accordance with the requirements of 21CFR 807.92

5.1 Submission Sponsor

Hebei HongSen Plastics Technology Co., Ltd Contact Person: Vincent Lu 15 Eastern Industrial Accumulation Area Nangong Town, Xingtai City, Hebei Province, China Tel: (086) 311-85656588 Submitter's FDA Registration Number: 3010582952

5.2 Submission Correspondent

Manton Business and Technology Services Contact Person: Charles Shen 853 Dorchester LN, Unit-B New Milford, NJ 08534 Tel: 608-217-9358 Email: cyshen@aol.com

5.3 Date of Summary: December 16, 2014

5.4 Device Name:

Proprietary Name: Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine) Common Name: Surgeon's glove Classification Name: Surgeon's glove Device Classification: -Regulation Number: 21 CFR 878.4460 Panel: General General & Plastic Surgery Product Code: KGO

ર્સ્ટ Predicate Device Information:

K122557, "Motex Powder Free Nitrile Surgical Gloves, White and Green Color", (1) manufactured by "Shanghai Motex Healthcare Co., Ltd."

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15 Eastern Industrial Accumulation Area, Nangong Town, Xingtai City, Hebei Province, China Tel: (086) 311-85656588

5.6 Device description:

The powder free nitrile surgical gloves described in this submission are also tested biocompatibility per ISO 10993-10. The test results conform to related requirements in the standard.

The product sterilization is performed using radiation and the procedure is validated per ISO 11137-2: 2006.

5.7 Indications for Use:

Comparison to Predicate Devices 5.8

The powder free nitrile surgical gloves, white, sterile are compared with the following Predicate Devices in terms of intended use, design, material, specifications, and performance.

K122557, "Motex Powder Free Patient Nitrile Surgical Gloves", manufactured by (1) "Shanghai Motex Healthcare Co., Ltd."

Substantial equivalence is established with respect to intended use, Labeling, performance, design, materials, and other applicable characteristics. Side-by-side comparison tables that include the following four areas are provided below:

A: Indication for Use, design and materials
B: Labeling (labels, instructions for use, promotional material) for the legally marketed device to which substantial equivalence is claimed.

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15 Eastern Industrial Accumulation Area, Nangong Town, Xingtai City, Hebei Province,China Tel: (086) 311-85656588

C: Performance data supporting substantial equivalence
A: Indications for Use. Design, and Material:

The following table shows similarities and differences of use, design, and material between subject device and the predicate devices.

Description	Subject Device (K140989)	Predicate Device (K122557)
Indication forUse	The powder free nitrile surgical glove(Brand Name: Titanfine) is a sterile andsingle use device made of syntheticrubber intended to be worn by operationroom personnel to protect a surgicalwound from contamination. The glovesdo not contain lubricating or dustingpowder.	A Surgeon's Glove is a sterileand single use device made ofsynthetic rubber intended to beworn by operation roompersonnel to protect a surgicalwound from contamination. Thelubricating or dusting powderused in the glove is excluded.
Basic Design	A device covering the hand and wristarea. Gloves have separate sheaths oropenings for each finger and the thumb.	Same
Materials	Nitrile rubber	Same
Size	6, 6.5, 7, 7.5, 8, 8.5, 9	6, 6.5, 7, 7.5, 8, 8.5
Single Use	Yes	Yes
Color	White	White and green
Sterile	Sterile (Irradiation)	Sterile (Irradiation)

Table 5.1: Comparison of Intended Use, Design, and Material

The subject device is essentially identical to the predicate device in terms of indications for use, design, and material between subject device and the predicate devices. The only minor difference is that the predicate device has both green and white color, while subject device in submission has only white color. This minor difference in color does not impact the efficacy and safety of the gloves, demonstrated by satisfactory performance and biocompatibility test results, and the fact that the white pigment of TiO2 has a well established safety profile.

B: Labeling:

The following table shows similarities and differences of key elements of the labeling between subject device and the predicate devices.

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15 Eastern Industrial Accumulation Area, Nangong Town, Xingtai City, Hebei Province, China Tel: (086) 311-85656588

Description	Subject Device(K140989)	Predicate Device(K122557)
Product Name	Yes	Yes
Indication for Use	Yes	No
Technical Characteristics (Powder, Nitrile, etc)	Yes	Yes
Manufacturer Name and Address	Yes	Yes
Product Model, Size, and Lot Number	Yes	Yes
Single Use Statement	Yes	Yes
Sterility Statement	Yes	Yes
Expiration Date	No	Yes
Information on Wrapper	Size, andLeft/Right	Size

	Table 5.2: Comparison of Key Elements in Labeling

The label for this subject device is identical to K122557, except for two minor differences. The first one is that the label for subject device has Indications for Use on it, while the second one being that the predicate device claims expiration date, while the subject device does not.

ﻥ Performance and Specifications

The following table shows similarities and differences of the specification/performance between subject device and the predicate devices. Tests were conducted following the recommended procedures outlined in the respective consensus standards, and results for Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine) met all relevant requirements in the specifications and test standards. The subject device/gloves are equivalent with the predicate device in terms of performance and technological characteristics.

Description	Subject Device (K140989)	Predicate Device (K122557)
Dimension	Length: ≥265 mmWidth: within ±6 nm of thespecified value in ASTM 3577:2009Palm, Finger, Cuff Thickness:≥0.10 mm	Length: ≥265 mmWidth: within ±6 nm of thespecified value in ASTM 3577:2009Palm, Finger, Cuff Thickness:≥0.10 mm
Tensile Strength (MPa)	≥17	≥17

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15 Eastern Industrial Accumulation Area, Nangong Town, Xingtai City, Hebei Province, China Tel: (086) 311-85656588

Tensile at 500 %Elongation (MPa)	≤ 7.0	≤ 7.0
Percent Elongation	≥650	≥650
Free of Pinhole	Free of pinholes at AQL = 1.5	Free of pinholes at AQL = 1.5
Residue Powder	≤ 2.0 mg	≤ 2.0 mg
Water Soluble Protein	≤ 200 µg/dm²	≤ 200 µg/dm²
Primary Skin Irritation(ISO 10993-10: 2010)	Not a primary skin irritant (Grade<1.0) under the conditions of study	Not a primary skin irritant
Dermal sensitization(ISO 10993-10: 2010)	Not a dermal sensitizer (Grade 0 or1) under the conditions of study	Not a dermal sensitizer

5.9 A brief discussion of the non-clinical testing data that was submitted, referenced or relied on to demonstrate that the Subject Device is safe and effective, and whose performance meets the requirements of its user-defined acceptance criteria and intended uses:

Powder Free Nitrile Surgical Gloves, White Color (Brand Name: Titanfine) meet requirements per ASTM D3577-09, ASTM D6124-06, ASTM D 5151-06, ASTM D5712-10 and ISO 10993-10. Its performance meets the requirements of its pre-defined acceptance criteria and intended uses.

A brief discussion of the clinical submitted, reference, or relied on in the 5.10 premarket notification submission for a determination of substantial equivalence.

Clinical data is not needed for gloves cleared by the 510(k) process.

5.11 Substantial Equivalent Conclusions

Based on the comparison of intended use, design, materials, and performance, the subject device is as safe and effective and substantially equivalent to the predicate device.

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).