PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

K162362 · Pms Tibbi Cihazlar Teknolojisi San VE Tic AS · FRG · Oct 13, 2017 · General Hospital

Device Facts

• Record ID: K162362
• Device Name: PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator
• Applicant: Pms Tibbi Cihazlar Teknolojisi San VE Tic AS
• Product Code: FRG · General Hospital
• Decision Date: Oct 13, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

Intended Use

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator, is a device intended to be used to enclose another medical device that is to be sterlized by a health care provider. It is intended to allow sterlization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Device Story

Device consists of medical-grade paper and laminated PET/PP film pouches/rolls; heat-sealed by healthcare providers to enclose medical instruments. Input: medical devices requiring sterilization. Transformation: packaging allows sterilant vapor (steam or EO) penetration to destroy microorganisms on instrument surfaces; chemical indicator ink on exterior changes color to distinguish processed from unprocessed units. Output: sterilized, sealed medical device. Used in clinical settings; operated by healthcare staff. Benefits: maintains sterility of instruments for 30 days post-sterilization. Clinical decision-making: color-change indicators provide visual confirmation that sterilization cycle was completed.

Clinical Evidence

Bench testing only. Testing included sterilant penetration, drying time, aeration, biocompatibility (ISO 10993-5), package integrity, material compatibility, and chemical indicator efficacy (ISO 11140-1). Results confirmed effective sterilant penetration, no cytotoxic effects, and maintenance of sterility per ANSI/AAMI/ISO 11607-1.

Technological Characteristics

Materials: medical-grade paper, laminated PET/PP film. Construction: heat-sealed sides. Sensing: Class 1 chemical process indicator ink (steam: pink to brown; EO: turquoise to yellow). Connectivity: N/A. Sterilization: steam (132°C, 4 min) or EO (725mg/L, 55°C, 50-80% RH, 60 min). Standards: ANSI/AAMI/ISO 11607-1, ISO 11140-1, ISO 10993-5, ASTM F88, ASTM F1929.

Indications for Use

Indicated for use by healthcare providers to enclose medical devices for sterilization via steam or ethylene oxide (EO) processes and to maintain sterility until use. Compatible with general medical devices, including those with stainless steel lumens.

Regulatory Classification

Identification

A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Predicate Devices

• SIGMA Sterilization Pouch and Roll (K102158)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.

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

October 13, 2017

Pms Tibbi Cihazlar Teknolojisi San Ve Tic As Derya Dikici Business Development Manager Karaduvar Mah.serbest Bolge, 11.cad No.46 Mersin Serbest Bolgesi, Akdeniz Mersin, 33020 TURKEY

Re: K162362 Trade/Device Name: PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: August 24, 2017 Received: September 11, 2017

Dear Derya Dikici:

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

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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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known) 162362

Device Name

## PMSSteripack Flat Sterilization Pouch (FP) and Roll(FL) with Chemical Indicator

Indications for Use (Describe)

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator, is a device intended to be used to enclose another medical device that is to be sterlized by a health care provider. It is intended to allow sterlization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

#### The recommended (and validated) sterilization cvcle parameters for all models (Sterilization Pouches (FP) and Rolls(FL) with Chemical Indicator) are:

- For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes. Validated minimum dry time is 20 minutes. ●
For EO sterilization; 100%ethylene oxide(EO) with a concentration of 725mg/l at 55 degrees C and 50o 80%relative humidity for 60 minutes. Aeration time is 8 hours.

Chemical process indicators on the exterior of the pouch and roll indicate by color change that the pouch has

undergone either a steam or ethylene oxide sterilization process.

Type1 steam indicator will change color from pink to brown after exposure to pre-vacuum steam sterilization process.

Type 1 ethylene oxide indicator will change from turquoise to ethylene oxide sterilization process.

As Worst Case Validated Load; general medical devices with stainless steel lumens with the following internal diameter (ID) and Maximum Lumen Lumen length can be processed in the validated steam and ETO sterilization cvcles as follows:

Table 1.Worst Case Validated Load and Lumen Claims.

| Pouch Size | Product<br>Code | Max.Load<br>Weight (Ibs.) | Max. lumen length<br>(mm) | Min. internal<br>diameter (mm) | Max # Lumens |
|--------------|-----------------|---------------------------|---------------------------|--------------------------------|--------------|
| 50 x 200 mm | FP 0520 | 0.062 | 50.8 mm | 1.5 mm | 1 |
| 200 x 300 mm | FP 2030 | 0.516 | 200 mm | 3.0 mm | 1 |
| 250 x 300 mm | FP 2530 | 0.520 | 200 mm | 3.0 mm | 1 |
| 500 x 600 mm | FP 5060 | 3.344 | 400 mm | 3.0 mm | 1 |

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Prescription Use (Part 21 CFR 801 Subpart D)

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Image /page/4/Picture/0 description: The image shows the logo for PMS. The logo consists of a red and gray abstract shape on the left, followed by the letters "PMS" in gray. The letters are large and bold, and they are spaced evenly apart.

## K162362

# 510 (k) Summary For "PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator"

## 1.0. Name, address and contact

## PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI

Karaduvar Mahallesi, Serbest Bölge 11.cad. No: 46 Mersin Serbest Bölgesi Akdeniz 33020 Mersin –TURKEY

| Phone | : | 90 324 2387042 – 90 541 648 6312 |
|-------------|---|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fax | : | 90 324 2386549 |
| Prepared by | : | Taner Ersen<br>Quality Management Representative |
| Contact | : | Derya Dikici<br>Business Development Manager<br>Phone : [phone] 541 648 6312<br>Fax : [phone]<br>E-mail : [e-mail] |

Date Prepared: October 13, 2017

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## 2. Device Name

Trade Name: PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator

Common/Usual Name: Sterilization Pouch and Roll (Flat)

Device Classification Name: Wrap, Sterilization - Indicator, Physical/Chemical Sterilization Process

Product Code: FRG - JOJ

Product Classification: Class II

21 CFR 880.6850, General Hospital

## 3. Predicate Device

K102158, SIGMA Sterilization Pouch and Roll

#### 4. Indications For Use

PMSSteripack Flat Sterilization Pouch (FP) and Roll (FL) with Chemical Indicator, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

#### The recommended (and validated) sterilization cycle parameters for all models (Sterilization Pouches (FP) and Rolls(FL) with Chemical Indicator) are;

For steam sterilization pre-vacuum cycle at 132 degrees C for 4 minutes. Validated . minimum dry time is 20 minutes.

. For EO sterilization; 100%ethylene oxide(EO) with a concentration of 725mg/l at 55 degrees C and 50-80%relative humidity for 60 minutes. Aeration time is 8 hours.

Chemical process indicators on the exterior of the pouch and roll indicate by color change that the pouch has undergone

either a steam or ethylene oxide sterilization process.

Type 1 steam indicator will change color from pink to brown after exposure to pre-vacuum steam sterilization process.

Type 1 ethylene oxide indicator will change from turquoise to yellow after exposure to ethylene oxide sterilization process.

As Worst Case Validated Load; general medical devices of stainless steel and devices with stainless steel lumens with the following internal diameter (ID) and Maximum Load weight and Maximum Lumen length can be processed in the validated steam and ETO sterilization cycles as follows;

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Table 1.Worst Case Validated Load and Lumen Claims.

| Pouch Size | Product<br>Code | Max.Load<br>Weight<br>(Ibs.) | Max. lumen<br>length<br>(mm) | Min. internal<br>diameter<br>(mm) | Max #<br>Lumens |
|--------------|-----------------|------------------------------|------------------------------|-----------------------------------|-----------------|
| 50 x 200 mm | FP 0520 | 0.062 | 50.8 mm | 1.5 mm | 1 |
| 200 x 300 mm | FP 2030 | 0.516 | 200 mm | 3.0 mm | 1 |
| 250 x 300 mm | FP 2530 | 0.520 | 200 mm | 3.0 mm | 1 |
| 500 x 600 mm | FP 5060 | 3.344 | 400 mm | 3.0 mm | 1 |

## 5. Device Description

PMSSteripack Flat Sterilization pouches (FP) and rolls (FL) with Chemical Indicator; are manufactured from medical grade paper/ laminated PET/PP film, by heat sealing on sides. Triple band seal provides three independent barriers to contamination, while reducing the risk of fiber tear.

PMSSteripack Flat Sterilization Pouches (FP) and Rolls (FL) with Chemical Indicator; are divided into 2 main groups as below;

- Sterilization Pouches, Flat: These pouches are manufactured from medical grade paper/plastic film that are heat sealed on 3 sides, the remaining open side is heat sealed by the end user.

- Sterilization Rolls, Flat: These rolls are manufactured from medical grade paper/plastic film that is heat sealed on opposite two sides. The required size is cut from the roll and the remaining open sides are heat sealed by the end user.

The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas.

After the sterilization process is completed, the sterility of the enclosed medical device is rnaintained for 30 days.

-List of Model Numbers are given in Table 2 and Table 3.

| Table 2. Product List of PMSSteripack Flat Sterilization Pouch (FP) with Chemical |
|-----------------------------------------------------------------------------------|
| Indicator. |

| PRODUCT LIST (FP) | | | | | | | | | |
|-------------------|-------------------------------------|--------------------------------------|-----------------------------------------|-----------------------------------------|------------------------------------|-------------------------------------------------|-------------------------------------------------------|---------------------------------|--------------------------|
| Product<br>Name | (A)<br>Total<br>Width<br>(mm)<br>±2 | (B)<br>Total<br>Height<br>(mm)<br>±5 | (A)<br>Total<br>Width<br>(in.)<br>±0.08 | (B)<br>Total<br>Height<br>(in.)<br>±0.2 | (L)<br>Seal<br>Width<br>(mm)<br>±2 | (V)<br>Single<br>Seal<br>Width<br>(mm)<br>min.2 | (P)<br>Distance<br>Between<br>2 Seals<br>(mm)<br>±0.1 | (S)<br>Diameter<br>(mm)<br>min. | (T)<br>Thickness<br>(μm) |
| FP0520 | 50 | 200 | 2 | 8 | 10 | 2 | 2 | 10 | 153±18 |
| FP0525 | 50 | 250 | 2 | 10 | 10 | 2 | 2 | 10 | 153±18 |
| FP0530 | 50 | 300 | 2 | 12 | 10 | 2 | 2 | 10 | 153±18 |
| FP0532 | 50 | 320 | 2 | 12¾ | 10 | 2 | 2 | 10 | 153±18 |
| FP0535 | 50 | 350 | 2 | 14 | 10 | 2 | 2 | 10 | 153±18 |
| FP7515 | 75 | 150 | 3 | 6 | 10 | 2 | 2 | 10 | 153±18 |
| FP7518 | 75 | 180 | 3 | 7 | 10 | 2 | 2 | 10 | 153±18 |
| FP7520 | 75 | 200 | 3 | 8 | 10 | 2 | 2 | 10 | 153±18 |
| FP7523 | 75 | 230 | 3 | 9 | 10 | 2 | 2 | 10 | 153±18 |
| FP7525 | 75 | 250 | 3 | 10 | 10 | 2 | 2 | 10 | 153±18 |
| FP7528 | 75 | 280 | 3 | 11 | 10 | 2 | 2 | 10 | 153±18 |
| FP7530 | 75 | 300 | 3 | 12 | 10 | 2 | 2 | 10 | 153±18 |
| FP7535 | 75 | 350 | 3 | 14 | 10 | 2 | 2 | 10 | 153±18 |
| FP7540 | 75 | 400 | 3 | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP7545 | 75 | 450 | 3 | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP0815 | 80 | 150 | 3¼ | 6 | 10 | 2 | 2 | 10 | 153±18 |
| FP0817 | 80 | 170 | 3¼ | 6¾ | 10 | 2 | 2 | 10 | 153±18 |
| FP0818 | 80 | 180 | 3¼ | 7 | 10 | 2 | 2 | 10 | 153±18 |
| FP0820 | 80 | 200 | 3¼ | 8 | 10 | 2 | 2 | 10 | 153±18 |
| FP0827 | 80 | 270 | 3¼ | 10¼ | 10 | 2 | 2 | 10 | 153±18 |
| FP0860 | 80 | 600 | 3¼ | 24 | 10 | 2 | 2 | 10 | 153±18 |
| FP0956 | 90 | 560 | 3½ | 22 | 10 | 2 | 2 | 10 | 153±18 |
| FP0960 | 90 | 600 | 3½ | 24 | 10 | 2 | 2 | 10 | 153±18 |
| FP0961 | 90 | 610 | 3½ | 24 | 10 | 2 | 2 | 10 | 153±18 |
| FP1015 | 100 | 150 | 4 | 6 | 10 | 2 | 2 | 10 | 153±18 |
| FP1018 | 100 | 180 | 4 | 7 | 10 | 2 | 2 | 10 | 153±18 |
| FP1019 | 100 | 190 | 4 | 7½ | 10 | 2 | 2 | 10 | 153±18 |
| FP1020 | 100 | 200 | 4 | 8 | 10 | 2 | 2 | 10 | 153±18 |
| FP1023 | 100 | 230 | 4 | 9 | 10 | 2 | 2 | 10 | 153±18 |
| FP1025 | 100 | 250 | 4 | 10 | 10 | 2 | 2 | 10 | 153±18 |
| FP1026 | 100 | 260 | 4 | 10¼ | 10 | 2 | 2 | 10 | 153±18 |
| FP1027 | 100 | 270 | 4 | 10¼ | 10 | 2 | 2 | 10 | 153±18 |
| FP1028 | 100 | 280 | 4 | 11 | 10 | 2 | 2 | 10 | 153±18 |
| FP1030 | 100 | 300 | 4 | 12 | 10 | 2 | 2 | 10 | 153±18 |
| FP1033 | 100 | 330 | 4 | 13 | 10 | 2 | 2 | 10 | 153±18 |
| FP1035 | 100 | 350 | 4 | 14 | 10 | 2 | 2 | 10 | 153±18 |
| FP1036 | 100 | 360 | 4 | 14 | 10 | 2 | 2 | 10 | 153±18 |
| FP1040 | 100 | 400 | 4 | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP1045 | 100 | 450 | 4 | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP1050 | 100 | 500 | 4 | 20 | 10 | 2 | 2 | 10 | 153±18 |
| FP1056 | 100 | 560 | 4 | 22 | 10 | 2 | 2 | 10 | 153±18 |
| FP1057 | 100 | 570 | 4 | 22 | 10 | 2 | 2 | 10 | 153±18 |
| FP1060 | 100 | 600 | 4 | 24 | 10 | 2 | 2 | 10 | 153±18 |
| FP1061 | 100 | 610 | 4 | 24 | 10 | 2 | 2 | 10 | 153±18 |
| FP1128 | 110 | 280 | 4¼ | 11 | 10 | 2 | 2 | 10 | 153±18 |
| FP1225 | 120 | 250 | 4¾ | 10 | 10 | 2 | 2 | 10 | 153±18 |
| FP1230 | 120 | 300 | 4¾ | 12 | 10 | 2 | 2 | 10 | 153±18 |
| FP1240 | 120 | 400 | 4¾ | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP1250 | 120 | 500 | 4¾ | 20 | 10 | 2 | 2 | 10 | 153±18 |
| FP1325 | 130 | 250 | 5 | 10 | 10 | 2 | 2 | 10 | 153±18 |
| FP1338 | 130 | 380 | 5 | 15 | 10 | 2 | 2 | 10 | 153±18 |
| FP1520 | 150 | 200 | 6 | 8 | 10 | 2 | 2 | 10 | 153±18 |
| FP1525 | 150 | 250 | 6 | 10 | 10 | 2 | 2 | 10 | 153±18 |
| FP1527 | 150 | 270 | 6 | 10¾ | 10 | 2 | 2 | 10 | 153±18 |
| FP1528 | 150 | 280 | 6 | 11 | 10 | 2 | 2 | 10 | 153±18 |
| FP1530 | 150 | 300 | 6 | 12 | 10 | 2 | 2 | 10 | 153±18 |
| FP1532 | 150 | 320 | 6 | 12¾ | 10 | 2 | 2 | 10 | 153±18 |
| FP1535 | 150 | 350 | 6 | 14 | 10 | 2 | 2 | 10 | 153±18 |
| FP1538 | 150 | 380 | 6 | 15 | 10 | 2 | 2 | 10 | 153±18 |
| FP1540 | 150 | 400 | 6 | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP1543 | 150 | 430 | 6 | 17 | 10 | 2 | 2 | 10 | 153±18 |
| FP1545 | 150 | 450 | 6 | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP1550 | 150 | 500 | 6 | 20 | 10 | 2 | 2 | 10 | 153±18 |
| FP1552 | 150 | 520 | 6 | 20¾ | 10 | 2 | 2 | 10 | 153±18 |
| FP1555 | 150 | 550 | 6 | 22 | 10 | 2 | 2 | 10 | 153±18 |
| FP1556 | 150 | 560 | 6 | 22 | 10 | 2 | 2 | 10 | 153±18 |
| FP1640 | 160 | 400 | 6¼ | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP1658 | 160 | 580 | 6¼ | 23 | 10 | 2 | 2 | 10 | 153±18 |
| FP1722 | 170 | 220 | 6¾ | 8¾ | 10 | 2 | 2 | 10 | 153±18 |
| FP1735 | 170 | 350 | 6¾ | 14 | 10 | 2 | 2 | 10 | 153±18 |
| FP1830 | 180 | 300 | 7 | 12 | 10 | 2 | 2 | 10 | 153±18 |
| FP1832 | 180 | 320 | 7 | 12¾ | 10 | 2 | 2 | 10 | 153±18 |
| FP1846 | 180 | 460 | 7 | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP1933 | 190 | 330 | 7½ | 13 | 10 | 2 | 2 | 10 | 153±18 |
| FP2020 | 200 | 200 | 8 | 8 | 10 | 2 | 2 | 10 | 153±18 |
| FP2025 | 200 | 250 | 8 | 10 | 10 | 2 | 2 | 10 | 153±18 |
| FP2027 | 200 | 270 | 8 | 10¾ | 10 | 2 | 2 | 10 | 153±18 |
| FP2030 | 200 | 300 | 8 | 12 | 10 | 2 | 2 | 10 | 153±18 |
| FP2033 | 200 | 330 | 8 | 13 | 10 | 2 | 2 | 10 | 153±18 |
| FP2035 | 200 | 350 | 8 | 14 | 10 | 2 | 2 | 10 | 153±18 |
| FP2040 | 200 | 400 | 8 | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP2041 | 200 | 410 | 8 | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP2045 | 200 | 450 | 8 | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP2050 | 200 | 500 | 8 | 20 | 10 | 2 | 2 | 10 | 153±18 |
| FP2060 | 200 | 600 | 8 | 24 | 10 | 2 | 2 | 10 | 153±18 |
| FP2128 | 210 | 280 | 8¼ | 11 | 10 | 2 | 2 | 10 | 153±18 |
| FP2135 | 210 | 350 | 8¾ | 14 | 10 | 2 | 2 | 10 | 153±18 |
| FP2140 | 210 | 400 | 8¼ | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP2142 | 210 | 420 | 8¼ | 16¾ | 10 | 2 | 2 | 10 | 153±18 |
| FP2228 | 220 | 280 | 8¾ | 11 | 10 | 2 | 2 | 10 | 153±18 |
| FP2235 | 220 | 350 | 8¾ | 14 | 10 | 2 | 2 | 10 | 153±18 |
| FP2242 | 220 | 420 | 8¾ | 16¾ | 10 | 2 | 2 | 10 | 153±18 |
| FP2525 | 250 | 250 | 10 | 10 | 10 | 2 | 2 | 10 | 153±18 |
| FP2530 | 250 | 300 | 10 | 12 | 10 | 2 | 2 | 10 | 153±18 |
| FP2535 | 250 | 350 | 10 | 14 | 10 | 2 | 2 | 10 | 153±18 |
| FP2538 | 250 | 380 | 10 | 15 | 10 | 2 | 2 | 10 | 153±18 |
| FP2540 | 250 | 400 | 10 | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP2545 | 250 | 450 | 10 | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP2550 | 250 | 500 | 10 | 20 | 10 | 2 | 2 | 10 | 153±18 |
| FP2735 | 270 | 350 | 10¼ | 14 | 10 | 2 | 2 | 10 | 153±18 |
| FP2745 | 270 | 450 | 10¼ | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP2835 | 280 | 350 | 11 | 14 | 10 | 2 | 2 | 10 | 153±18 |
| FP2840 | 280 | 400 | 11 | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP2845 | 280 | 450 | 11 | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP2850 | 280 | 500 | 11 | 20 | 10 | 2 | 2 | 10 | 153±18 |
| FP2857 | 280 | 570 | 11 | 22 | 10 | 2 | 2 | 10 | 153±18 |
| FP3038 | 300 | 380 | 12 | 15 | 10 | 2 | 2 | 10 | 153±18 |
| FP3040 | 300 | 400 | 12 | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP3042 | 300 | 420 | 12 | 16¾ | 10 | 2 | 2 | 10 | 153±18 |
| FP3045 | 300 | 450 | 12 | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP3046 | 300 | 460 | 12 | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP3050 | 300 | 500 | 12 | 20 | 10 | 2 | 2 | 10 | 153±18 |
| FP3055 | 300 | 550 | 12 | 22 | 10 | 2 | 2 | 10 | 153±18 |
| FP3060 | 300 | 600 | 12 | 24 | 10 | 2 | 2 | 10 | 153±18 |
| FP3245 | 320 | 450 | 12¾ | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP3250 | 320 | 500 | 12¾ | 20 | 10 | 2 | 2 | 10 | 153±18 |
| FP3255 | 320 | 550 | 12¾ | 22 | 10 | 2 | 2 | 10 | 153±18 |
| FP3346 | 330 | 460 | 13 | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP3540 | 350 | 400 | 14 | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP3545 | 350 | 450 | 14 | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP3550 | 350 | 500 | 14 | 20 | 10 | 2 | 2 | 10 | 153±18 |
| FP3552 | 350 | 520 | 14 | 20¾ | 10 | 2 | 2 | 10 | 153±18 |
| FP3555 | 350 | 550 | 14 | 22 | 10 | 2 | 2 | 10 | 153±18 |
| FP3660 | 360 | 600 | 14 | 24 | 10 | 2 | 2 | 10 | 153±18 |
| FP4040 | 400 | 400 | 16 | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP4045 | 400 | 450 | 16 | 18 | 10 | 2 | 2 | 10 | 153±18 |
| FP4055 | 400 | 550 | 16 | 22 | 10 | 2 | 2 | 10 | 153±18 |
| FP4060 | 400 | 600 | 16 | 24 | 10 | 2 | 2 | 10 | 153±18 |
| FP4141 | 410 | 410 | 16 | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP4150 | 410 | 500 | 16 | 20 | 10 | 2 | 2 | 10 | 153±18 |
| FP4241 | 420 | 410 | 16¾ | 16 | 10 | 2 | 2 | 10 | 153±18 |
| FP4250 | 420 | 500 | 16¾ | 20 | 10 | 2 | 2 | 10 | 153±18 |
| FP4255 | 420 | 550 | 16¾ | 22 | 10 | 2 | 2 | 10 | 153±18 |
| FP4260 | 420 | 600 | 16¾ | 24 | 10 | 2 | 2 | 10 | 153±18 |
| FP4656 | 460 | 560 | 18 | 22 | 10 | 2 | 2 | 10 | 153±18 |
| FP4661 | 460 | 610 | 18 | 24 | 10 | 2 | 2 | 10 | 153±18 |
| FP4858 | 480 | 580 | 19 | 23 | 10 | 2 | 2 | 10 | 153±18 |
| FP5060 | 500 | 600 | 20 | 24 | 10 | 2 | 2 | 10 | 153±18 |

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| | Table 3. Product List of PMSSteripack Flat Sterilization Roll (FL) with Chemical |
|------------|----------------------------------------------------------------------------------|
| Indicator. | |

| PRODUCT LIST (FL) | | | | | | | | |
|-------------------|--------------------------------------------|-------------------------------------------|----------------------------------------------|--------------------------------------------|-----------------------------------------|-------------------------------------------------|------------------------------------------------------------|--------------------------|
| Product<br>Name | (A)<br>Total<br>Width<br>(cm)<br>$\pm$ 0.2 | (B)<br>Total<br>Length<br>(m)<br>$\pm$ %1 | (A)<br>Total<br>Width<br>(in)<br>$\pm$ 0.008 | (B)<br>Total<br>Length<br>(ft)<br>$\pm$ %1 | (L)<br>Seal<br>Width<br>(mm)<br>$\pm$ 2 | (V)<br>Single<br>Seal<br>Width<br>(mm)<br>min.2 | (P)<br>Distance<br>Between<br>2 Seals<br>(mm)<br>$\pm$ 0.1 | (T)<br>Thickness<br>(μm) |
| FL 0530 | 5 | 30 | 2 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 7530 | 7.5 | 30 | 3 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 1030 | 10 | 30 | 4 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 12530 | 12.5 | 30 | 5 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 1530 | 15 | 30 | 6 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 2030 | 20 | 30 | 8 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 2330 | 23 | 30 | 9 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 2530 | 25 | 30 | 10 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 3030 | 30 | 30 | 12 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 3530 | 35 | 30 | 14 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 3830 | 38 | 30 | 15 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 4030 | 40 | 30 | 16 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 4530 | 45 | 30 | 18 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 5030 | 50 | 30 | 20 | 100 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 0560 | 5 | 60 | 2 | 200 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 7560 | 7.5 | 60 | 3 | 200 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 1060 | 10 | 60 | 4 | 200 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 12560 | 12.5 | 60 | 5 | 200 | 10 | 2 | 2 | 153 $\pm$ 18 |
| FL 1560 | 15 | 60 | 6 | 200 | 10 | 2 | 2 | 153 $\pm$ 18 |
| | | | | | | | | |
| FL 2060 | 20 | 60 | 8 | 200 | 10 | 2 | 2 | 153±18 |
| FL 2360 | 23 | 60 | 9 | 200 | 10 | 2 | 2 | 153±18 |
| FL 2560 | 25 | 60 | 10 | 200 | 10 | 2 | 2 | 153±18 |
| FL 3060 | 30 | 60 | 12 | 200 | 10 | 2 | 2 | 153±18 |
| FL 3560 | 35 | 60 | 14 | 200 | 10 | 2 | 2 | 153±18 |
| FL 3860 | 38…