Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical and biological properties of surgical sutures, with no mention of AI or ML technologies.

Therapeutic

No
The device is a surgical suture (REXLON/REXSIL), indicated for soft tissue approximation and/or ligation. While used in a therapeutic context (surgery), the suture itself is not performing a therapeutic action by treating or alleviating a disease or condition; rather, it is a tool used to physically join tissues.

Diagnostic

No

The device description clearly states that these are "surgical sutures," which are used for "general soft tissue approximation and/or ligation," indicating a therapeutic rather than a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description clearly states that the devices are surgical sutures made of physical materials (polyamide and silk) and may include stainless steel needles. This indicates a physical hardware component, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "general soft tissue approximation and/or ligation," which are surgical procedures performed directly on the body. IVDs are used to examine specimens (like blood, urine, or tissue) taken from the body to provide information about a person's health.
Device Description: The device is described as a "surgical suture," which is a physical material used to close wounds or tie off blood vessels during surgery. This is a therapeutic device, not a diagnostic one.
Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting analytes, or providing diagnostic information.
Performance Studies: The performance studies listed are related to the physical properties of the suture (diameter, tensile strength, needle attachment), sterility, biocompatibility, and packaging integrity. These are typical tests for surgical devices, not IVDs.

In summary, the REXLON and REXSIL sutures are surgical devices used for physical intervention in the body, not for performing diagnostic tests on samples taken from the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

REXLON' is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.
REXSIL is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Product codes (comma separated list FDA assigned to the subject device)

GAR, GAP

Device Description

REXLON is a sterilized nonabsorbable monofilament surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXLON suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. REXLON sutures are not coated. The sutures are dyed black (Logwood) or blue (FD&C Blue No.2) to enhance visibility in tissue. The suture is also available undyed (Natural).
REXLON suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture.

REXSIL is a sterilized nonabsorbable silk surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.
REXSIL suture is a nonabsorbable, sterile, surgical suture composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. REXSIL sutures are processed to remove the natural waxes and gums. REXSIL suture is dyed black (Logwood) and coated with silicone. REXSIL suture is also available undyed (Natural).
REXSIL suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surqical suture.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

general soft tissue, ophthalmic procedures

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)

Non-Clinical Test Conclusion:
USP 35 SUTURES - DIAMETER
USP 35 SUTURES - NEEDLE ATTACHMENT
USP 35 TENSILE STRENGTH
USP Nonabsorbable Surgical Suture
ASTM F88-09. Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
USP STERILITY TEST
USP 36, ; Pyrogen Test
ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide-Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices:
USP Bacterial Endotoxin Limit;
ISO 10993, Biological Evaluation of Medical Devices: Including:
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)
Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

REXLON were evaluated in accordance with the listed tests above.
Real-time and accelerated aging stability testing was performed to support shelf life of REXLON. Testing confirmed that the sutures conform to USP requirements for nonabsorbable sutures, are biocompatible per ISO 10993-1, and are stable over the proposed shelf life

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.

K080684, K982646

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

Regulation Number and Section

§ 878.5020 Nonabsorbable polyamide surgical suture.

(a)
Identification. Nonabsorbable polyamide surgical suture is a nonabsorbable, sterile, flexible thread prepared from long-chain aliphatic polymers Nylon 6 and Nylon 6,6 and is indicated for use in soft tissue approximation. The polyamide surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. monograph for nonabsorbable surgical sutures; it may be monofilament or multifilament in form; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

March 2, 2017

SM ENG CO., Ltd % Mr. Sanglok Lee Wise Company, Inc. #306, 3 Daerim-ro 27ga-gil Yeongdeungpo-gu, 07413 KR

Re: K161633

Trade/Device Name: REXLON®, REXSIL® Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable polyamide surgical suture Regulatory Class: Class II Product Code: GAR, GAP Dated: January 24, 2017 Received: January 31, 2017

Dear Mr. Lee:

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.

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 devicerelated 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.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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,

David Krause -S

for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K161633

Device Name

REXLON

Indications for Use (Describe)

REXLON' is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

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)

3

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the nollection of informating data sources, gather and needed and complete of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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."

4

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161633

Device Name

REXSIL

Indications for Use (Describe)

REXSIL is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

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)

FORM FDA 3881 (1/14)

5

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review institutions, search existing data sources, gather and maintain the data needed and complete and reviouslion of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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."

6

510(k) Summary

The assigned 510(k) Number: K161633

Date of Submission: January 24, 2017

Applicant

Company name: SM ENG CO., LTD Address: 46, Nakdong-daero 1302beon-gil, Sasang-gu, Busan, Korea TEL: +82 51 305 8016 FAX: +82 51 305 8021 Email: leesg@sm-eng.net

Submission Correspondent

Sanglok, Lee Wise COMPANY Inc. #1005, 11-19, Gamasan-ro 27-gil, Guro-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org

Subject Device Information

1. Nylon Monofilament Suture With or Without Needle

1.1 Proposed Device Identification

Proprietary Name: REXLON Common Name: Nonabsorbable Polyamide Suture With or Without Needle Device Class: Class II Regulation Number: 21 C.F.R. 878.5020 Product Code: GAR Device Classification Name: Suture, Nonabsorbable, Synthetic, Polyamide

1.2 Indication for use

REXLON is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

7

1.3 Predicate devices

Predicate device 01 510(k) Number: K080684 Device Name: WG-Surgical Sutures with Needle Classification Name: Suture, Nonabsorbable, Synthetic, Polyamide Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD.

Predicate device 02 510(k) Number: K982646 Device Name: Reli Classification Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE Manufacturer: AILEE CO LTD.

1.4 Device Description

REXLON is a sterilized nonabsorbable monofilament surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.

REXLON suture is a nonabsorbable, sterile surgical monofilament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. REXLON sutures are not coated. The sutures are dyed black (Logwood) or blue (FD&C Blue No.2) to enhance visibility in tissue. The suture is also available undyed (Natural).

REXLON suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. Available suture size is as below.

Dyed suture Black (Logwood): USP 11-0 ~ USP 1
i Dyed suture Blue (FD&C Blue No.2): USP 8-0 ~ USP 2
Undyed suture (Natural): USP 8-0 ~ USP 1

1.5 Non-Clinical Test Conclusion

USP 35 SUTURES - DIAMETER

USP 35 SUTURES - NEEDLE ATTACHMENT

USP 35 TENSILE STRENGTH

USP Nonabsorbable Surgical Suture

ASTM F88-09. Standard Test Method for Seal Strength of Flexible Barrier Materials;

ASTM F1929-98(2004) Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration

USP STERILITY TEST

USP 36, ; Pyrogen Test

ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide-Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices:

USP Bacterial Endotoxin Limit;

ISO 10993, Biological Evaluation of Medical Devices: Including:

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd 1:2006)

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

8

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008)

Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)

Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2006)

REXLON were evaluated in accordance with the listed tests above.

Real-time and accelerated aging stability testing was performed to support shelf life of REXLON. Testing confirmed that the sutures conform to USP requirements for nonabsorbable sutures, are biocompatible per ISO 10993-1, and are stable over the proposed shelf life

1.6 Substantially Equivalent Conclusion

	Table 1: Substantial Equivalence Comparison

| Property | Proposed device
REXLON | Predicate device 01
WG-Surgical Sutures
with Needle | Predicate device 02
Reli |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K161633 | K080684 | K982646 |
| Product Code | GAR | GAR | GAR |
| Regulation No, | 21 C.F.R. 878.5020 | 21 C.F.R. 878.5020 | 21 C.F.R. 878.5020 |
| Class | II | II | II |
| Sterile | Yes | Yes | Yes |
| Single Use | Yes | Yes | Yes |
| Intended use | Indication for use is in
general soft tissue
approximation and/or
ligation, including use in
ophthalmic procedures, | Indication for use is in
general soft tissue
approximation and/or
ligation, including use in
ophthalmic procedures. | Indication for use as non
absorbable sutures is in
general soft tissue
approximation and/or
ligation, including use in |
| | but not for use in
cardiovascular or neural
tissue. | | cardiovascular,
ophthalmic, neural
tissue. |
| Configuration | Nonabsorbable
Polyamide Suture With
Needle | Nonabsorbable
Polyamide Suture With
Needle | Nonabsorbable
Polyamide Suture With
Needle |
| | | Suture | |
| Raw Suture Material | polyamide surgical
suture from long-chain
aliphatic polymers Nylon
6 and Nylon 6,6 | polyamide surgical
suture from long-chain
aliphatic polymers Nylon
6 and Nylon 6,6 | polyamide surgical
suture from long-chain
aliphatic polymers Nylon
6 and Nylon 6,6 |
| Suture Manufacturer | Ashaway Line & Twine
Mfg. Co. | Pearsalls Limited | Ashaway Line & Twine
Mfg. Co. |
| Color (Colorant) | Dyed suture Black
(Logwood), Blue
(FD&C Blue No.2) and
Undyed suture (Natural) | Dyed suture Black
(Logwood), Blue &
phthalocyanine blue
(FD&C Blue No.2) and
Undyed suture (Natural) | Dyed suture Black
(Logwood), Blue
(FD&C Blue No.2) and
Undyed suture (Natural) |
| Coating material | Not used | Not used | Not used |
| Absorbable/Nonabsorb
able | Nonabsorbable | Nonabsorbable | Nonabsorbable |
| Braided/Monofilament | Monofilament | Monofilament | Monofilament |
| Suture Size | Available suture sizes
are standard according
to USP requirements
Available suture size is
as below.
#1 Dyed suture Black
(Logwood): USP 11-
0USP 1
#2 Dyed suture Blue
(FD&C Blue No.2): USP
8-0USP 2
#3 Undyed suture
(Natural): USP 8-0~USP
1 | Available suture sizes
are standard according
to USP requirements | Available suture sizes
are standard according
to USP requirements |
| | | | |
| Length of Suture | 15cm, 20cm, 30cm,
35cm, 40cm, 45cm,
50cm 60cm, 70cm,
75cm, 80cm, 100cm,
150cm, 200cm | Unknown | 15cm, 20cm, 30cm,
45cm, 50cm |
| Diameter of Suture | The suture diameters of
proposed device comply
with the diameter
requirement listed in
U5P 35 Diameter. | The suture diameters of
proposed device comply
with the diameter
requirement listed in
U5P 35 Diameter. | Meet the requirements
defined in the USP |
| Tensile strength | The tensile strengths of
proposed device comply
with the tensile
requirement listed in
U5P 35 Tensile
Strength | The tensile strengths of
proposed device comply
with the tensile
requirement listed in
U5P 35 Tensile
Strength | Meet the requirements
defined in the USP |
| Needle Attachment | The bond between
suture and needle of the
applicant device meet
the requirements defined
in USP 35 . | The bond between
suture and needle of the
applicant device meet
the requirements defined
in USP 35 . | Meet the requirements
defined in the USP |
| Needle | | | |
| Material | Stainless Steel | Stainless Steel | Stainless Steel |
| Needle type | Reverse Cutting, Taper
point, Spatula | Taper, cutting, spatual,
blund ,taper cut,
diamond, premimum
cutting and square | Spatula, taper point,
Blunt point |

9

10

The proposed device, REXLON, is determined to be Substantially Equivalent (SE) to the predicate device, WG-Surgical Sutures with Needle (K080684) and Reli (K982646) in respect of safety and effectiveness.

11

2. Nonabsorbable Silk Suture With or Without Needle

2.1 Proposed Device Identification

Proprietary Name: REXSIL Common Name: Nonabsorbable Braided Silk Suture With or Without Needle Device Class: Class II Regulation Number: 21 C.F.R. 878.5030 Product Code: GAP Device Classification Name: Suture, Nonabsorbable, Silk

2.2 Indication for use

REXSIL is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

2.3 Predicate devices

Predicate device 01 510(k) Number: K080684 Device Name: WG-Surgical Sutures with Needle Classification Name: SUTURE, NONABSORBABLE, SILK Manufacturer: FOOSIN MEDICAL SUPPLIES INC.LTD

Predicate device 02 510(k) Number: K982646 Device Name: Reli Classification Name: SUTURE, NONABSORBABLE, SILK Manufacturer: AILEE CO LTD.

2.4 Device Description

REXSIL is a sterilized nonabsorbable silk surgical suture made out of polyamide used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.

REXSIL suture is a nonabsorbable, sterile, surgical suture composed of an organic protein call fibroin. This protein is derived from the domesticated species Bombyx mori (b. More) of the family Bombycidae. REXSIL sutures are processed to remove the natural waxes and gums. REXSIL suture is dyed black (Logwood) and coated with silicone. REXSIL suture is also available undyed (Natural).

REXSIL suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surqical suture. Available suture size is as below.

Dyed suture Black (Logwood): USP 8-0 ~ USP 2
Undyed suture (Natural): USP 7-0 ~ USP 2

2.5 Non-Clinical Test Conclusion

USP 35 SUTURES - DIAMETER USP 35 SUTURES - NEEDLE ATTACHMENT USP 35 TENSILE STRENGTH USP Nonabsorbable Surgical Suture ASTM F88-09. Standard Test Method for Seal Strength of Flexible Barrier Materials; ASTM F1929-98-98 Standard Test Method for Detecting Seal Leaks in Porous Medical

12

Package by Dye Penetration

USP STERILITY TEST

USP ; Pyrogen Test

ISO 11135-1:2007 Sterilization of health care products- Ethylene oxide- Part 1: Requirements for development, validation and routing control of a sterilization process for medical devices;

USP Bacterial Endotoxin Limit;

ISO 10993, Biological Evaluation of Medical Devices:

Includina: